Role Summary
A clinical-stage oncology biotech is looking to hire an experienced Director / Sr. Director of Statistical Programming to build the programming function for the business
Responsibilities:
- Serve as the programming head across the company's studies, including pivotal trials in oncology.
- Develop and validate SDTM, ADaM, and TLFs in support of both ongoing studies and regulatory submissions.
- Oversee CRO programming deliverables, ensuring high quality, accuracy, and compliance with timelines.
- Partner closely with Biostatistics, Clinical Development, Data Management, and Regulatory to ensure alignment on programming needs and strategy.
- Support data delivery for CSR packages, regulatory submissions, and exploratory analyses.
- Contribute to process development, documentation, and implementation of programming best practices.
- Act as a key technical advisor on submission readiness and data standardization.
Requirements:
- Bachelor’s or Master’s degree in a relevant field
- Extensive SAS programming experience within the biotech/pharma sector, ideally with oncology exposure.
- Strong working knowledge of CDISC standards (SDTM, ADaM) and submission requirements.
- Track record of managing CROs and delivering study-level programming outputs.
- Excellent communication skills and ability to operate effectively in a cross-functional, fast-paced setting.
Compensation DOE - $240k - $320k salary + bonus, equity and supporting package