Responsibilities :
- Attending multi-disciplinary team meetings, representing the statistical programming function.
- Create or review and approve statistical programming plans at study and project level.
- Provide input on key study-related documents produced by other functions (e.g. 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.
Requirements :
- Minimum of 5 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 Oncology 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.
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