Related skills
r sas cdisc sdtm adam📋 Description
- Lead statistical input for trial design, protocols, and sample size.
- Develop and review SAPs.
- Oversee analyses for clinical studies (Phase I-IV).
- Collaborate with Clinical, Data Management, and Programming teams.
- Support regulatory submissions (FDA/EMA) and responses.
- Guide and review SDTM/ADaM work and CDISC standards.
🎯 Requirements
- Master’s or PhD in Statistics, Biostatistics, or related field.
- 5+ years of experience in pharma/CRO clinical trials.
- Strong experience in Vaccines and Infectious Diseases.
- Proficiency in SAS; knowledge of R is a plus.
- Strong understanding of CDISC (SDTM/ADaM) standards.
- Excellent communication and stakeholder management.
🎁 Benefits
- Global full-service CRO with 28+ years in pharma.
- Client-facing role with collaborative culture.
- Structured career development and training opportunities.
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