The Associate Director, Statistical Programming will provide strategic and technical leadership for statistical programming activities across one or more therapeutic areas. Establish and maintain statistical reporting standards, drive efficient and high-quality programming processes, ensure compliance with CDISC and regulatory requirements, and support clinical development planning and execution across multiple indications.
Key Responsibilities
- Lead statistical programming activities; align deliverables with business priorities, study objectives, and program timelines.
- Collaborate with cross-functional teams to ensure accurate, consistent, and timely data reporting; ensure quality and timeliness of statistical analysis, reporting, and regulatory submission deliverables.
- Apply technical expertise to promote programming environment/technology and best practices.
- Establish and maintain resource management and planning.
- Manage and mentor statistical programming and data analytics team members (guidance, training, feedback, technical oversight); ensure CDISC and regulatory compliance for regulatory submission and inspection readiness.
- Manage and collaborate with CROs to oversee programming activities and ensure adherence to timelines and quality expectations.
Qualifications
- Masterβs in Statistics/Math/Computer Science (or related) with 10+ years SAS programming in pharma/biotech/CRO; or Bachelorβs with 15+ years.
- Experience across early and late phase/registrational trials.
- Strong reporting process, regulatory requirements, and software development life cycle experience.
- SAS expertise; R or Python knowledge is a plus.
- Hands-on CDISC experience (SDTM, ADaM) and programming from raw data from EDC and eCOA sources.
- Strong written/verbal communication; cross-functional matrix leadership and proactive influence.
- Demonstrated leadership experience.
Compensation/Benefits
- Base salary: $166,000.00β$242,000.00; discretionary annual bonus; 401(k), medical/dental/vision/life insurance, paid time off, health and wellness program.