Responsibilities:
* 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.
* ttending multi-disciplinary team meetings, representing the programming function.
* Create or review and approve programming plans at study and project level.
* ssist 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.
Requirements:
* 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.