Related skills
cross-functional collaboration leadership sas cdisc sdtm📋 Description
- Provide strategic leadership for Statistical Programming across therapies
- Lead global programming team and ensure high-quality outputs for regulatory submissions
- Oversee SDTM, ADaM, and TLF deliverables under CDISC
- Collaborate with Biostatistics, Data Management, Clinical Ops, and Regulatory teams
- Drive process improvements and adoption of new technologies/tools
- Support regulatory submissions (NDA, BLA, MAA) and health authority queries
🎯 Requirements
- Master’s or PhD in Statistics, Biostatistics, or related field
- 12–18+ years in Statistical Programming in pharma/CRO
- SAS programming; CDISC SDTM/ADaM; regulatory submissions
- Proven leadership of large, global programming teams
- Strong knowledge of clinical trial processes and data standards
- Experience interacting with regulatory authorities preferred
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