Job Description

• 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 clinal al study data as tables, listings, and graphs for electronic submission to regulatory agencies.
• Attending multi-disciplinary team meetings, representing the programming function.
• Create or review and approve programming plans at study and project level.
• 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.
• Oversee work of internal contract programmers and external vendors.
• Provide time and resource estimates for project planning.
• Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.

• Bachelor's degree in computer science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; master's degree preferred.
• Minimum 6 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).
• Solid verbal and written communication skills.
• Experience in pharmacokinetics/pharmacodynamics modeling a plus.
• Familiarity with CDISC standards, including SDTM and ADaM models.

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