Principal Statistical Programmer (Remote)
rief Description :
The Clinical Data Integration and Standards (CDI&S) group is accountable for data engineering and data pipeline activities within the Integrated Data Analytics and Statistical Programming (IDASP) group, primarily involving SDTM transformations for clinical trial and real-world data.
The Principal Statistical Programmer provides Statistical Programming project and technical leadership on CDI&S projects, and supports other CDI&S team members.
They are responsible for the development and quality of all aspects of CDI&S deliverables on their assigned projects in accordance with departmental SOPs and guidelines.
They delegate tasks appropriately and track progress. The Principal Statistical Programmer may also construct estimates of project resource requirements and timelines and routinely briefs management on accomplishments, status of projects, and any issues.
Essential Functions / Responsibilities
- Attend multi-disciplinary team meetings, representing the CDI&S 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 (. CRFs, Data Management Plan, .
- Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
- Implement in-house data standards.
- Develop software validation procedures and test plans, as necessary.
- Create and document archives of software, outputs, and analysis files.
- Create and maintain department SOPs and guidelines related to clinical programming.
- Oversee work of internal contract programmers and external vendors.
- Provide time and resource estimates for project planning.
Required Knowledge, Skills, and Abilities
- Minimum of 7 years of experience in developing software for clinical trials using the SAS system. Experience in real-world data a plus.
- Skilled in programming with SAS. Basic knowledge of additional programming languages such as R or Python.
- Good knowledge of statistics and general drug development processes. Basic knowledge of the Oncology drug development process and data structures is a plus.
- 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.
- Expert knowledge of SDTM and Define-XML standards. Knowledge of CDASH and ADaM a plus.
- Solid verbal and written communication skills.
Required / Preferred Education and Licenses
Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; Master’s Degree preferred.
FOR US-BASED CANDIDATES ONLY
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