About the Role
Designs, develops, tests, maintains, validates, and documents SAS programs to evaluate clinical data for clinical and non-clinical studies. Provides technical expertise for programming standards and procedures.
Your Contributions
- Serves as primary project team representative; delegates work
- Generates SDTM domains, ADaM datasets, and Define.xml files (incl. specification files)
- Generates analysis datasets, tables, figures, and listings
- Reviews program output for consistency; reviews/maintains/approves study documents
- Supports supplemental/exploratory analyses and ad-hoc requests
- Programs/tests/documents global utility tools per standards/validation
- Provides expertise in standards, analysis, and reporting; develops/maintains departmental procedures
- Performs programming (macro language, advanced data manipulation, statistical procedures)
- Implements data management plans to meet deadlines; liaises with clinical management/subcommittees
- May train/mentor programmers; other duties as assigned
Requirements
- BS/BA in CS/math/stats or related + 4+ years biopharma/CRO statistical programming (advanced SAS: Base/Stat/Macro/graph) AND 3+ years lead/supervisory project experience
OR Masterβs + 2+ years similar
OR PhD + similar
- Knowledge of ICH, CDISC, 21 CFR Part 11, FDA guidelines
- Strong SAS (Base/Stat/Macro/graph), R/STAT or similar; SDTM/ADaM/Define.xml; statistical program validation/documentation; relational databases
- Strong communication, analytical/problem-solving, organization, project management, teamwork
- Proficiency with Word/Excel/PowerPoint
Compensation & Benefits
- Annual base salary: $110,800β$151,000; annual bonus (target 20%); equity long-term incentive eligibility; retirement match; paid vacation/holidays/personal days; caregiver/parental and medical leave; medical/prescription/dental/vision coverage.
Application Instruction
- Apply even if your experience doesnβt match all outlined qualifications.