Senior Manager/Associate Director, Statistical Programming
Skills
- Advanced hands-on SAS programming experience
- Strong knowledge of CDISC standards (ADaM, SDTM, SEND)
- Experience creating submission-ready TFLs and displays
- CRO oversight and vendor management experience
- Solid understanding of statistics and oncology drug development
- Proven ability to perform thorough QC and validation of programming outputs
- Excellent verbal and written communication and collaboration skills
- Ability to respond rapidly to ad hoc and emergent requests
Responsibilities
- Provide technical oversight and review of CRO-developed statistical programming deliverables for clinical studies.
- Design, develop, and validate SAS programs to produce ADaM/SDTM/SEND datasets and TFLs for clinical study reports and submissions.
- Create, review, and approve programming specifications, SAPs, and TFL shells prior to programming.
- Perform and document quality control and validation of datasets, tables, listings, and graphs according to CDISC and regulatory standards.
- Support ad hoc, interim, and rapid-turnaround analyses for monitoring, safety queries, and regulatory questions.
- Collaborate with multidisciplinary teams (statisticians, data managers, clinical staff) to ensure data quality and analysis readiness.
- Provide input on eCRFs, data management plans, and external data specifications to ensure programming alignment.
- Develop SAS validation procedures, test plans, and documentation for programming activities.
Education
- Bachelor's degree in statistics, biostatistics, computer science, or related field
- Advanced degree (MS/PhD) in a quantitative discipline preferred
Benefits
- Competitive base salary ($184,000 - $200,000) with annual performance incentive bonus
- New hire equity package
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off and paid holidays
- Opportunities for professional development and cross-functional collaboration
Average salary estimate
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