Related skills
sas biostatistics clinical trials cdisc regulatory submissions📋 Description
- Provide statistical leadership for Phase I–IV trials across multiple therapeutic areas.
- Lead SAPs, protocol statistics, and randomization specifications.
- Oversee analyses and interpretation of trial data; ensure timely outputs.
- Collaborate with programming teams to deliver outputs and support regulatory submissions.
- Mentor junior statisticians; contribute to proposals and business growth.
- Ensure ICH-GCP compliance and adherence to SOPs.
🎯 Requirements
- Master’s or PhD in Statistics, Biostatistics, Mathematics, or related field.
- 10–15 years in Biostatistics within CRO, pharma, or biotech.
- Strong knowledge of clinical trial methods and regulatory requirements.
- Hands-on experience supporting global regulatory submissions.
- Expert in SAS and CDISC SDTM/ADaM/TLFs.
- Experience leading sponsor interactions and cross-functional teams.
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