Growing biotech/pharma company seeking an experienced Statistical Programming Lead to support Phase I-III clinical development programs. This individual will provide technical leadership for statistical programming activities, regulatory submissions, and cross-functional study support.
Responsibilities:
- Lead statistical programming activities across clinical studies and programs
- Develop and oversee SDTM, ADaM, TLFs, define.xml files, reviewer guides, and other submission deliverables
- Partner with Biostatistics, Data Management, Clinical Development, and Regulatory teams to support study execution and reporting
- Support global regulatory submissions and ensure compliance with CDISC and regulatory standards
- Drive programming standards, automation initiatives, process improvements, and mentoring of junior team members
Key Requirements:
- BS/MS in Statistics, Biostatistics, Computer Science, Mathematics, or related field
- 10+ years of statistical programming experience within biotech/pharma; oncology experience preferred
- Prior experience serving as a lead programmer for clinical studies and regulatory submissions
- Strong SAS programming expertise (Base SAS, SQL, Macros); R and/or Python preferred
- Deep knowledge of CDISC standards (SDTM, ADaM, define.xml) and global submission requirements
- Experience supporting NDA, BLA, and/or MAA submissions
- Strong technical leadership, communication, and cross-functional collaboration skills