Overview
We are a mid-sized biotech company seeking an experienced Director of Statistical Programming to lead programming activities across clinical development. This role combines strategic leadership with hands-on delivery in a collaborative, fast-paced environment.
Key Responsibilities
* Lead and develop a small team of statistical programmers
* Oversee delivery of SDTM, ADaM datasets and TLFs
* Ensure compliance with CDISC standards and regulatory requirements (MHRA, EMA, FDA)
* Provide hands-on support using SAS and R as needed
* Collaborate cross-functionally with Biostatistics, Data Management, and Clinical teams
* Support regulatory submissions (e.g., CTA, NDA, MAA)
Requirements
* 10+ years’ experience in statistical programming (biotech/pharma/CRO)
* Strong expertise in SAS and R
* Proven team leadership experience
* Deep knowledge of CDISC standards (SDTM, ADaM)
* Experience supporting regulatory submissions
Desirable
* Experience in a mid-sized or growing biotech
* Vendor/CRO management experience