Director of Statistical Programming
About the role
For our client, we are seeking a Director of Statistical Programming to join the team of a leader in the Pharmaceuticals & Biotech space. This role will lead statistical programming efforts across multiple clinical studies, with a strong focus on deliverables that support regulatory-quality data submissions. The Director will partner closely with biostatistics, clinical operations, data management, and external partners to ensure programming outputs are accurate, compliant, and delivered on time. This position also plays a key role in strengthening standards, automation, and reporting capabilities within a fast-paced clinical development environment. Location: Remote - US based candidates only, no visa sponsorship available.
Responsibilities
- Lead statistical programming activities for multiple clinical studies
- Review and validate CRO deliverables for compliance and accuracy
- Manage programming deliverables for study monitoring and data integration
- Collaborate with external partners for programming tasks
- Establish and enhance SAS reporting environment and automation tools
- Represent statistical programming in cross-functional teams
- Develop and maintain statistical programming standards and SOPs
Qualifications
- MS in Statistics, Computer Science, or a related field with 10+ years of experience, or BS with 12+ years of experience
- 5+ years of experience as a lead statistical programmer
- Extensive knowledge of CDISC standards and FDA SDTCG
- CRO oversight experience preferred
- Experience in NDA/BLA submissions and knowledge of biostatistics compliance requirements
- Strong capability in managing multiple projects in a fast-paced environment
- Experience integrating AI tools into clinical data pipelines is highly desirable
Pay
Compensation: $241,600 – $269,200 annually
Benefits
- Market-leading compensation package
- 401(k) with employer match
- Employee Stock Purchase Program (ESPP)
- 100% employer-paid medical, dental, and vision premiums
- Flexible, take-what-you-need paid time off
- Comprehensive paid medical and parental leave
- Career development opportunities with feedback and continuous education