About the Role
Leads major statistical programming efforts for a clinical program area of responsibility. Develops system capabilities roadmap for in-house development and external vendor selection. Designs, develops, tests, maintains, validates, and documents SAS programs to evaluate clinical data; provides expert technical advice on program development process, tools/software, standards, and procedures.
Your Contributions (include, but are not limited to)
- Provide expert technical leadership for Biometrics; contribute to Biometrics functional strategy.
- Lead and mentor statistical programmers; support analysis/reporting for clinical and nonclinical studies.
- Lead end-to-end statistical programming work-streams on multidisciplinary teams.
- Define and implement programming standards/conventions; build statistical programming infrastructure.
- Recommend workforce planning to ensure timely resourcing.
- Manage vendor selection; validate vendor programming (e.g., CDISC implementation, analysis reporting, conventions).
- Support e-submission requirements (annotated CRF, dataset files, define documents).
- Serve as primary/lead programmer for agency reporting (DSUR/Annual Report, IB updates); act as lead and/or QC statistical programmer as needed.
Requirements
- BS/BA in CS/Math/Stats or related + 8+ years biopharma (or CRO) statistical programming with advanced SAS (Base/Stat/Macro/graph) and CDISC data structures; 2+ years supervisory/lead experience; managing large projects and vendors.
OR Masterβs + 6+ years OR PhD + 4+ years.
- Expert knowledge: statistical programming SOPs; relational databases; ICH, CDISC, 21 CFR Part 11, FDA guidelines; SAS plus R/STAT; SDTM/ADaM/Define.xml; writing/validating/documenting programs and integrated libraries.
- Proven cross-functional project management in a regulated environment; strong leadership, communications, problem-solving, analytical skills; ability to meet multiple deadlines.
Benefits/Compensation (as stated)
- Base salary: $156,900β$214,000; annual bonus target 30%; equity long-term incentive eligibility; retirement match, paid vacation/holidays/personal days, caregiver/parental and medical leave, and medical/dental/vision coverage.