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About the Role
As the Associate Director, Statistical Programming you will lead statistical programming activities across our clinical development programs.
Reporting to the Head of Biostatistics, you will be responsible for building internal capabilities, and ensure high-quality programming deliverables for regulatory and clinical milestones. You will work with key internal stakeholders, oversee vendors, perform CDISC compliance checks, program ad hoc datasets and TFL and ensure regulatory acceptance of datasets. You must have experience within a Biotech, Pharma or CRO and technical depth to work independently as the lead statistical programmer.
This is an exciting opportunity to join a growing team with ongoing phase III development as the first statistical programming team member, with the opportunity to build a programming infrastructure while directly collaborating with internal stakeholders to ensure the TFL meet company needs. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.
Key Responsibilities
- Lead the development, validation, and documentation of statistical programming deliverables (e.g., SDTM, ADaM datasets, tables, listings, and figures) for clinical studies and regulatory submissions.
- Collaborate with internal teams and CRO partners to ensure quality, consistency, and compliance with CDISC standards and regulatory requirements.
- Serve as the primary programming lead across multiple studies or clinical programs.
- Develop and maintain programming standards, tools, and processes to support scalable clinical development.
- Provide strategic input to study design, data flow, and database structures from a programming perspective.
- Review and provide input on protocols, statistical analysis plans (SAPs), CRFs, and data specifications.
- Support preparation of regulatory documents including clinical study reports (CSRs), ISS/ISE, and responses to health authority questions.
- Partner with biostatistics, data management, medical writing, regulatory, clinical development, and clinical operations teams to ensure alignment of timelines and deliverables.
- Contribute to vendor selection, oversight, and performance management related to programming activities.
Experience
- Bachelor’s or Master’s degree in Computer Science, Statistics, Mathematics, or related field.
- Strong proficiency in SAS programming; experience with R or Python a plus.
- In-depth knowledge of CDISC standards (SDTM and ADaM), FDA/EMA regulatory requirements, and ICH guidelines.
- Experience with eCTD submission programming and contributing to BLA/NDA/MAA filings preferred.
- Strong attention to detail and commitment to producing high-quality, audit-ready deliverables.
- Excellent organizational and communication skills with a proactive, solution-oriented mindset.
- Ability to work effectively in a lean, cross-functional, start-up environment.
