Principal Programmer Resume Sample
Jazlyn Wyman
780 Shyanne Square,
Chicago,
IL
+1 (555) 635 2285
Work Experience
Principal Programmer
11/2017
-
PRESENT
New York, NY
- Perform detailed study of the functional requirements and evaluate appropriate technologies to satisfy the requirements
- Interact with Functional Service provider (FSP) at a portfolio level to confirm understanding of Celgene Library for study consumption
- Participate in meetings with FSP at a portfolio level as needed
- Work Internally and externally with different teams to implement DCR capability and process improvements
- As required, participate in process improvement initiatives or other non-clinical project activities
- Develops advanced MACROs for general use of programmers
- Problem solving and solution oriented; programming representation in the Clinical Project Team and IIS project team
Project Lead / Principal Programmer
10/2014
-
09/2017
Chicago, IL
- Internal and external satisfaction with final programming outputs used for the Clinical Project Development Program as assessed by customers, IIS project team/Project Lead/ Program Head
- Effectiveness of communication and team behaviors as assessed by the other members of the Clinical Project Team and IIS project team
- Quality and timeliness of programming contributions as assessed by the Clinical Project Team, IIS project team/Project Lead/ Program Head
- Ability and effectiveness in training and mentoring programmers in the IIS project teams
- Determine an efficient project programming strategy that utilizes customers' standards and procedures
- Develop project-level programming specifications for analysis datasets and pooled datasets for a project
- Lead the production of statistical outputs for clinical study reports, regulatory submissions (e.g., Summary of Clinical Safety, Summary of Clinical Efficacy, Risk Management Plan/safety update), responses to health authority questions, publications, and market promotions
- Ensure the quality control of all programs, specifications and statistical outputs within a study project
Senior Principal Programmer, Statistical
05/2009
-
08/2014
San Francisco, CA
- Ensure that programming-related documents are consistent, and comply with Data Science's and customers' standards, by reviewing case report forms, statistical analysis plans, data structures specifications, and specifications for tables, listings and figures
- Archival of project programs and associated documentation
- Mentor programmers in the functional expertise required for project support. 10.Support the development of, and the training of users in, new programming applications
- Develop advanced, general-purpose programming functions for deployment across multiple projects
- Maintain advanced knowledge of programming languages (e.g., SAS and R)
- Regularly elicit customers' satisfaction levels with Data Science's programming services. Identify service areas requiring attention
- Encourage customer participation in the PLS customer satisfaction (CSAT) survey
- Manage the outsourcing of programming activities from Data Science to an approved vendor in accordance with Scientific Services vendor management procedures
- Assist the Group Lead in the assessment of applicants for programming roles within Data Science
Education
Upper Iowa University
2004 - 2008
Bachelor's Degree in Life Science
Professional Skills
- Proven experience in development of advanced programming functions with high programming efficiency; strong programming and problem-solving skills
- Strong skills in mobile and web technologies, including AngularJS, HTML5 and supporting frameworks, e.g. Ionic
- Excellent verbal and written communication skills and influence stakeholders
- Experience performing SAS statistical programming for clinical trials, with proven track records of increasing responsibilities
- Mentor junior programmers in more advanced programming skills
- Proven ability to effectively act as a programmer present at
- Grow with the business; stretch yourself and learn new skills and domains
How to write Principal Programmer Resume
Principal Programmer role is responsible for programming, clinical, database, design, security, credit, training, java, oncology, architecture.
To write great resume for principal programmer job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Principal Programmer Resume
The section contact information is important in your principal programmer resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Principal Programmer Resume
The section work experience is an essential part of your principal programmer resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous principal programmer responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular principal programmer position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Principal Programmer resume experience can include:
- Work effectively in a multi-cultural context as a good team member
- Able to effectively assess and mitigate risk within a protocol or drug project and proactively determine the need and/or level of escalation
- Develop, programming, testing and maintaining computer validation/edit checks in RAVE, Oracle Clinical and/or Inform (Central Designer) if applicable
- Experience leading and managing small to medium-sized development teams running parallel development swim lanes
- Work experience in a programming role preferably supporting clinical trials/ or in the pharmaceutical industry (5 years for MS Statis
- Experience in planning and overseeing collaborative team
Education on a Principal Programmer Resume
Make sure to make education a priority on your principal programmer resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your principal programmer experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Principal Programmer Resume
When listing skills on your principal programmer resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical principal programmer skills:
- Strong skills in Oracle, SQL, and relational databases
- Good understanding of regulatory requirements relevant to statistical programming (e.g. Good Clinical Practice)
- Good SAS programming skill required
- Encouraging attitude with a strong capability of inspiring others and ensuring a positive learning environment
- Working knowledge and experience coding in Java, JSP, and Oracle
- Demonstrates expertise in the handling and processing of upstream data including multiple data sources, data workflow, eDC, SDTM
List of Typical Experience For a Principal Programmer Resume
1
Experience For Project Lead / Principal Programmer Resume
- Lead/participate in the development of tools/macros to support standards (e.g., tools to create and validate define files and ADaM received from vendors)
- Review computer validation/edit checks if applicable
- Professional experience or equivalent in client development for mobile, desktop or web applications
- Support the development of, and the training of users in, new programming applications
- Manage the outsourcing of programming activites from Data Science to an approved vendor in accordance with Scientific Services vendor management procedures
2
Experience For Senior Principal Programmer Resume
- Assist Data Manager on development of eCRF specifications and review according to the protocol
- Develop, program, test and maintain clinical trial databases and data entry screens using Rave in accordance with Celgene standards
- Represent Clinical and Statistical Programming in meetings with internal cross-functional and external customers
- Knowledge of creating all necessary files, documents and analyses to support electronic submissions in eCTD format
- Ensures the collection of programs/outputs and issues are adequately managed for programming activities to achieve business outcomes
- Applies learning from previous activities to result in quicker and more efficient completion of the current task
3
Experience For Senior Principal Programmer, Statistical Resume
- Guide team development and testing efforts towards successful project delivery
- Assist in the collection and documentation of user's requirements, development of user stories, estimates, testing strategies, and work plans
- Build networks to achieve influence with other functions and represent as Programming technical expert
- Archival of project programs and associated documentation. 9.Mentor programmers in the functional expertise required for project support
- Control access to database and perform snapshots, database lock and freeze activities
4
Experience For Cloud Principal Programmer Analyst Resume
- Provide support to data operations in the maintenance and roll out of standard programs including performing consistency review against standard CRFs (e.g. TLG shells, Data Review programs, SAE reconciliation, External data programs, SDTM, ADaM)
- Monitor study specific legacy CRF metadata for compliance with Celgene standard conventions
- Train internal people and vendors to implement standards (e.g, ADaM, data review tools)
- Performs risk/benefit and feasibility analysis on potential future projects
- Provide recommendations for application and system improvements
- Deliver the Product Lead’s vision of the core game
- Act as liaison with vendors to establish transfer specifications and Celgene standards
- Back-up peer programmer per assignment
- Project manage multiple complex studies form startup through database lock
5
Experience For Senior Principal Programmer, Clinical Resume
- Manages Libraries and associated object used for study configuration which have been approved through governance
- Supports Disease Indication scientist from various therapeutic functions to proactively create new commonly used CRF’s which could be consumed by study
- Maintains various EDC libraries with disease indication scientist
- Maintains consistency between Rave Library and MDR and/or other standards (if applicable)
- Develop, program, test and maintain data review listings in Rave, Jreview and/or SAS for data review purposes
- Work closely with statisticians and medical monitors for pre-specified and ad hoc study data analyses; work with data management personnel to identify data issues
- Generate SDTM datasets, ADaM datasets, tables, listings, figures and project specific macros and formats; import/export external data from/to other platforms and other software packages
- Prepare data specifications describing all datasets and variables
6
Experience For Principal Programmer, Standards Liaison Resume
- Perform data checks as needed, to ensure integrity and correctness of data displays, prepare documentation for programs
- Perform external data loads, i.e., labs, ECGs, etc., as needed and perform data reconciliations
- Review CRFs/eCRFS, edit check specifications and table mock-ups; maintain and approve protocol specific documents as necessary
- Knowledge of clinical database design, specifically electronic data capture
- Data Management and Pharmacovigilance processes in clinical trials
- Acts as a subject matter expert and works as a lead within own discipline to investigate new technology as directed
- Provides technical contribution to complex tasks
- Shares learnings with peers and contributes to internal technical discussions/forums
7
Experience For Principal Programmer, Clinical Resume
- Initiates new directions and novel strategies to achieve department goals
- Collaborate with other software developers, QA specialists, business analysts and software architects to plan, design, develop, test, and maintain enterprise level web services and business applications built on Java technologies
- Lead and participate in peer-reviews of solution designs and related code
- Prepare technical documentation such as users' manuals
- Lead/participate in department and/or cross-functional process improvement initiatives as well as special projects and create efficiencies within programming processes
- Routinely interface with cross-functional team members during the study startup and execution
- Lead/Participate in programming team meetings when appropriate
- Responsible for preparing reports on analyses, findings, and project progress, and presents results to management and/or customer personnel
- Provide programming input to CRF, External Data, SAP, analysis file specifications, and tables, figures, and listings (TLFs) shells
8
Experience For Associate Principal Programmer Resume
- Create Data Definition Tables (DDT) and converting TLFs to the required format for eSubmission
- Partner with CROs and act as a primary point of contact for statistical programming activities
- Provide statistical programming input into the SOW activities and review associated budget
- Accountable for the quality of elements of project programming work worldwide
- Reports to Programming Team Leader
- Responsible for Oracle based Billing and Revenue Management systems
- Provides support to develop Web based applications including online customer service for agency components to be able to deliver their services online
- Ensure consistency and adherence to standards and governance within their therapeutic area and the department
- Align with the department and company strategy and model
9
Experience For Principal Programmer / Technical Lead Resume
- Provides technical and analytic input to analytic team
- Consults with end-users to analyze specified methods and procedures, identify problems, and document specific requirements
- Oversee development of SAS programs to generate derived analysis datasets, perform analysis, and TLFs
- Collaborate with engineering, design, user experience, product and analytics teams to identify needs, evaluate requirements, write specifications, and design and implement complex software solutions
- Write well designed, efficient and testable code with one or more Object Oriented languages (C++, C#, Java, Objective-C, Swift etc.) and their associated frameworks
- Be a proven expert in one or more engineering domains such as rendering, networking, mathematics, animation, physics, AI, UI/UX, native app development, build systems etc
- Act as the strategic computer programming leader to provide support for all aspects of the clinical development process including, but not limited to, clinical development plans, regulatory submissions, programming and information deliverables, commercialization and scientific utilization data for our client’s products
- Lead the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM and RDB databases by these partners
10
Experience For Principal Programmer / Analyst Resume
- Oversee the quality of all deliverables, holding partners and providers accountable for the quality of their deliverable
- Identify opportunities to improve the methodology and provide practical solutions for problems
- Leadership role able to lead and direct project work
- Team commitment: priorities attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team. Be proactive Excellent collaboration required – needs the energy to work across global & functional boundaries
- Decision making: constructively challenge others and be receptive to challenge in bringing clarity and robustness (evidence based) to decision making within the team
- Issue resolution: work collaboratively with the project team to resolve issues, irrespective of whether or not the issues are functional in nature
List of Typical Skills For a Principal Programmer Resume
1
Skills For Project Lead / Principal Programmer Resume
- Develop and validate technical programming specifications for transforming raw data using SDTM standards
- Demonstrates expertise in providing outputs to meet downstream requirements including ADaM, Data Definition Table, e-submission
- Proficient in programming languages and demonstrated proficiency in using SAS to produce derived analysis datasets and produce TLFs
- Provide timely excellent programming support according to global project strategies
- Related experience in analytic programming, data extraction, querying databases/data warehouses and data analysis
- Experience with Installing and configuring OBIEE, OAE, ODI and Oracle’s pre-built applications
2
Skills For Senior Principal Programmer Resume
- Experience working in database systems and environments, including Oracle and Unix
- Lead/Support to the development, validation, maintenance and enhancement of Client global macros as well as training on the same
- Pharmaceutical/CRO experience as a SAS programmer supporting clinical trials for regulatory submissions
- As a programmer with progressive responsibilities in a pharmaceutical/CRO setting, or comparable relevant experience
- Experience with QA teams, testing strategies, and tools
3
Skills For Senior Principal Programmer, Statistical Resume
- Experience with automated testing, scripts, and tools
- Directly related Java development computer programming experience
- Directly related computer programming experience
- Advanced knowledge of / experience with SAS, or R, and other relevant programming software
- Working experience in clinical trial development
- Experience of creating a number of deep and complex game projects
4
Skills For Cloud Principal Programmer Analyst Resume
- Tatistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry
- Excellent Listener - receptive to both positive and negative feedback as well as ideas that are not your own
- Experience with jQuery or JavaScript
- Lead/Participate in the development, validation and maintenance of standard programs
- Relevant professional experience or an equivalent combination
- Scala/PHP/Java/ C++/Objective-C experience (we love polyglot engineers!)
- Write SAS programs to generate/validate SDTM and derived analysis datasets(ADaM), perform analysis, and TFLs
5
Skills For Senior Principal Programmer, Clinical Resume
- Contribute to the development of best practice to improve quality, efficiency and effectiveness
- Accountable for Good Information Practice
- Excellent collaboration required – needs the energy to work across global & functional boundaries
- Experience in data analysis and programming
- Developing, programming, and testing data review listings in SAS and/or reporting tool for data review purposes if applicable
6
Skills For Principal Programmer, Standards Liaison Resume
- Caring attitude with inherent compassion
- Willing to do whatever it takes - has never said, “That is not my job”
- Bring a deep understanding of algorithms, design patterns, debugging and memory/performance optimization
- Provides input to staff involved in writing and updating technical documentation such as users manuals; product specifications; and training materials
- Lead the implementation of standard naming convention for directories, programs, outputs and macros provide on-going training and monitor for adherence
- Primary Programming point of contact with CRO partners regarding Celgene Programming related standards
- Lead/ participate in the development of Programming Standard Operating Procedures, Working Procedures and Guidance Documents
- Assist in defining and implementing strategies regarding configuration management, build management, release management, and deployment
7
Skills For Principal Programmer, Clinical Resume
- Maintain in-house trials which could include (develop programming, testing and maintaining clinical trial databases) in accordance with Celgene standards
- Responsible for planning, developing, testing, and has the ability to document highly complex applications programs
- Project management, provides and maintain project plan for projects/study including milestones, tasks, and coordination of programming activities
- Provide broader technical knowledge and expertise (e.g. UNIX scripting, computing environments)
- Knowledge of multiple programming languages – including PL/SQL, SAS, Python, C#
- Knowledge of FDA/ICH guidelines and industry standard practices regarding programming
- Apply programming expertise to problems, problem solving and quality focus
- Mentor/coach programmers in functional expertise and process for project support; as required, support training/development of new programming applications
- Author, review, approve and train on department procedures including SOPs, Working Practices and Guidance Documents
8
Skills For Associate Principal Programmer Resume
- Represent programming during internal audits as well as Health Authority audits
- Perform adhoc flexible and rapid programming arising from questions generated from planned analyses and results
- Lead programming support to the regulatory submissions including specification and delivery of overview data bases, output and response to regulatory questions
- Conduct systems analysis and traffic monitoring of the billing systems
- Actively contribute to process improvement efforts, including the leadership of solution teams
9
Skills For Principal Programmer / Technical Lead Resume
- In depth understanding of statistical terminology, clinical tests, medical terminology, and protocol designs
- Communicate with the client on a day-to-day basis while managing daily activities
- Acts as key statistical programming contact for internal and external business partners
- Identify recurring problems and initiates process improvement
- Monitor department computing environment for compliance to Client standards and best practices
- Provide department training as needed
- A thorough understanding of the end to end clinical trial process
- Knowledge of several of the following areas is desirable
- Lead the development and delivery of training
10
Skills For Principal Programmer / Analyst Resume
- Great potential/Capability to provide programming leadership to cross -functional teams at the study and or project level
- Hands on creation and maintenance of legacy RAVE database standard CRFs including standard specification document
- Provide support as a subject matter expert during the implementation of studies in the MDR
- Represent Programming on standards governance committee
- Lead/participate in process improvement initiatives regarding clinical trial database standards
- Maintain current applications which includes, but is not limited to, bug fixes, feature enhancements and performance tuning
- Provide oversight for programming deliverables performed by MedImmune’s functional service provider
- Review synopsis and/or protocol and provide Data Manager with comments for the Synopsis Review Committee (SRC) meeting
List of Typical Responsibilities For a Principal Programmer Resume
1
Responsibilities For Project Lead / Principal Programmer Resume
- Good programming practices
- Extensive knowledge of Open CDISC Validator
- Able to leverage experience to innovate and streamline workflows
- Experience in Regulatory submissions
- Good clinical practices
- Performs system integrations activities, application updates, and user acceptance testing
2
Responsibilities For Senior Principal Programmer Resume
- Advanced knowledge of the fundamental concepts, practices, and procedures used in computer programming
- R&D, GMD, Biometrics & Information Sciences and Programming Group
- Communication: agree on how to communicate decisions, successes and escalation of issues etc. – speak with one voice instead of separate roles
- Provide technical input to protocol and other plans at the development phase of a study
- Provide input to the development of data capture tools for a clinical study
- Oversees CDISC/SDTM conversions with both internal and external partners
3
Responsibilities For Senior Principal Programmer, Statistical Resume
- Create Business Intelligence (BI) reports to analyze problems in customers' invoices, investigate root causes and propose solutions
- Solve the ordering and billing problems by identifying root causes, facilitating improvements and proposing accurate solutions which result in increased invoice accuracy
- Facilitate improvements in Enterprise Billing System by recommending essential changes to optimize the system
- Provide technical support to Contract Administrators by solving invoices, credit memo generations, and data inconsistency issues
- Provide support in developing the site concept, interface design, and architecture of the web-site. Provide support for the implementation of interfaces to applications
- Generates and maintains all required documentation including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRF)s, database creation, coding setup, edit check procedures, import setup and processing, export setup and processing, listings, and profile reporting
- Monitors applications proactively for workflow alerts, system errors, and performance issues
- Participates in and provides input at project review and departmental review meetings. Participates in bid defenses
- Ensures high quality deliverables by providing senior review of ’program level’/multi-study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits
4
Responsibilities For Cloud Principal Programmer Analyst Resume
- Manages project level metrics, progress, and status, for large programs of studies from key sponsors. Monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Assists with the creation of change orders
- Provides leadership, mentorship, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams and/or requestors to clarify and finalize specifications and uses expanded technical skills to meet evolving project needs
- Attends Quick Start Camps (QSCs) in the lead Clinical Programmer role for assigned studies
- Assists with management of application vendors and serves as an initial escalation contact. Monitors vendor service level agreements (SLAs) and reports metrics to upper management
- Supervises the implementations of upgrades and new modules of remotely hosted vendors, acquiring all documentation and storing in the relevant areas
- Lead the execution and support of Systems and Applications Support (SaAS) strategy and ensure alignment with department strategy
5
Responsibilities For Senior Principal Programmer, Clinical Resume
- Provide technical support to users within the department for systems and 3rd party applications, including answering/resolving user issues pertaining to the system and/or programming environment
- Experience with DevOps and respective tool chains
- Related software development experience
- Lead the creation of automated tools to assist with monitor for adherence/compliance to Client standards and best practices
- Conduct periodic audits are conducted on the data files to ensure compliance to standard processes as well as best practices
- Identify efficiencies/optimization needed in technology and propose/share solutions /or utilities to improve the same across the department
- Proactively anticipate problems, identify root causes and work with manager to implement creative solutions
- Lead cross functional system related projects as assigned
- Influence other functions and represent as department technical expert
6
Responsibilities For Principal Programmer, Standards Liaison Resume
- Coach and advise junior programmers to identify solutions
- Computer skills: detailed knowledge of clinical database design (Rave), proficiency with SAS data sets and conversion procedures, knowledge of MS Office program suite
- Proficiency in the use of SAS and/or Oracle PL/SQL or equivalent software tools
- Demonstrated ability to manage the outsourcing or externalization of statistical programming work in the clinical trials setting (e.g. Working with CROs, academic institutions)
- IT-I (SSBI) Favorable Background Check
- IAT-II Certification required at Start (CCNA Security, CSA +, GICSP, GSEC, Security + CE or SSCP)
- MCSD or MCSE Certification required within 6 months of Hire
- Directly related computer programming experience. Highly proficient in designing and developing web pages that draw in data from multiple sources
- Explain complex technical principles to non-technical staff
7
Responsibilities For Principal Programmer, Clinical Resume
- With a BA/BS, 9 to 12 years’ experience in Statistics, Software Development, Clinical Data Management, Clinical Research, or Database Design & Development
- Demonstrated expertise in working with PK/PD (ClinPharm)
- Working knowledge of database design/structures and basic statistics
- Keep abreast of evolving regulatory, industry, and technology changes and demands, e.g., CDISC, SDTM, ADaM, eDC
- A passion for computer games; specifically social, mobile and strategy
- Free fruit & soft drinks 23 days holiday
- B&I drives good design to generate the data needed for quality decision making. The goal of B&I is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and shaping the external environment whilst accessing and implementing innovative solutions
- Programming is the department that oversees and delivers the programming aspects of clinical development, manages and maintains the end to end standards and manages and maintains the Analysis and Reporting production tools and the information infrastructure
- TA Programming is the group that oversees and delivers all the programming contribution to internal decision making, regulatory submissions and reporting and commercial activities for the TA portfolio of projects
8
Responsibilities For Associate Principal Programmer Resume
- Gathers and/or clarifying business and technical requirements with data requestors
- Maintain existing codebase
- Integrated summary safety/efficacy analyses for regulatory filing
- Safety data and coding dictionaries
- Provide programming input to CRF, SDTM specifications, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells
- Create Data Definition Tables (DDT) and converting TFLs to the required format for e-Submission
- Knowledgeable of the drug indications within a therapeutic area, their analysis trends, and their effects on data submission standards
- BS in Mathematical, Statistical, Computer Science or Life Science
9
Responsibilities For Principal Programmer / Technical Lead Resume
- Effective English verbal and written communication skills in relating to colleagues and associates both inside and outside the organization control approach to work
- Oversee outsourced tasks to third party vendors and ensures their performance meets the agreed timelines, quality and budget requirements established for the project or study
- Defines, develops and embeds standards within a function, or therapeutic area in accordance with industry standards
- Provide technical advice to other teams and departments and work with other disciplines outside of the department to solve complex problems
- Proactively identify, assess and resolve the impact of decisions/actions from other groups. Define criteria for assessing alternative solutions and determine the optimal approach. Make decisions in face of unusual and conflicting information
10
Responsibilities For Principal Programmer / Analyst Resume
- Encourage and embed key behaviours from staff
- Build credibility and presence with internal and external customers
- Ensures project teams adherence to department standards, processes and SOPs
- Supports department initiatives and task forces and contribute to department standards and processes
- Ensure that documents and specifications are consistent and comply with company standards by providing input into eCRFs and data structures, tables, listings and figures for Phase I-IV clinical trials and submission activities within the responsible drug project
- Lead/program (according to established specifications) analysis datasets, pooled datasets, listings, tables, figures, and listings for Phase I-IV clinical trials and for regulatory submissions (e.g., SCS, SCE and RMP/safety update) and for other project support (e.g. publications and market promotion) according to established milestones
- Responsible for the preparation of Case Report Tabulations for the submission as required
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