Clinical SAS ProgrammerKatalyst HealthCares & Life Sciences • Philadelphia, PA
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Clinical SAS Programmer
Katalyst HealthCares & Life Sciences • Philadelphia, PA
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Minimum of years of experience in developing software for clinical trials using the SAS system. Skilled in programming with SAS. Knowledge of additional programming languages a plus. Good knowledge of statistics and drug development process. Experience as a lead programmer for NDAs / BLAs. Experience overseeing the work of internal contractors and external vendors (CROs) . Experience in pharmacokinetics / pharmacodynamics modeling a plus. Familiarity with CDISC standards, including SDTM and ADaM models . Solid verbal and written communication skills.
Responsibilities :
- Attending multi-disciplinary team meetings, representing the programming function.
- Create or review and approve programming plans at study and project level.
- Provide input on key study-related documents produced by other functions ( CRFs, Data Management Plan, SAPs, etc.)
- Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
- Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies.
- Assist statisticians by suggesting algorithms to address Client analysis requests.
- Develop software validation procedures and test plans, as necessary.
- Create and document archives of software, outputs, and analysis files.
- Create and maintain department SOPs related to clinical programming.
Requirements :
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