Director Statistical Programming

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

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