Remote, 12-month initial contract with potential to extend long term
Senior Statistical Programmer
- Develop or review and QC CDISC-compliant datasets (SDTM & ADaM) and corresponding documentation for electronic submission.
- Develop SAS programs to generate or QC displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies, internal deliverables, and publications.
- Ability to write new SAS macros or incorporate existing SAS macros into individual programs.
- Review and provide input on key study-related documents (e.g., CRFs, SAPs, etc.)
- Review and remain compliant with SOPs and Technical Guide documents related to Statistical Programming.
- Review and update documentation for tracking programming assignments and progress.
- Review, update, provide input and follow programming plans.
- Provide time and resource estimates for programming assignments and project planning.
- Assist statisticians, clinicians & other study-team members by suggesting algorithms and data displays to address novel analysis or data review requests.
Desired knowledge, skills, and abilities
- Skilled programming with SAS programs and macros. Knowledge of additional programming languages like R or Python is a plus.
- At least 10 years of experience working on CDISC standards (including SDTM and ADaM models), Tables, Listings and Figures.
- In-depth knowledge of clinical statistics and drug development process.
- Experience as lead programmer at study and/or molecule level.
- Solid verbal and written communication skills.
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