Senior statistician Consultant- V&I (Vaccines & Infectious Diseases)

Key Responsibilities

• Lead statistical input for clinical trial design, including protocol development and sample size calculations
• Develop and review Statistical Analysis Plans (SAPs)
• Provide oversight of statistical analyses for clinical studies (Phase I–IV)
• Collaborate with cross-functional teams including Clinical, Data Management, and Programming
• Interpret study results and contribute to clinical study reports (CSRs)
• Support regulatory submissions (e.g., FDA, EMA) including responses to health authority queries
• Guide and review work of statistical programmers (SDTM/ADaM, TLFs)
• Ensure compliance with CDISC standards and regulatory guidelines
• Participate in safety and efficacy analyses, including interim analyses
• Provide strategic input for ISS/ISE and integrated analyses

Required Qualifications

• Master’s or PhD in Statistics, Biostatistics, or related field
• 5+ years of experience in clinical trials within pharma/CRO
• Strong experience in Vaccines & Infectious Diseases
• In-depth knowledge of clinical trial methodology and statistical principles
• Experience with regulatory submissions (FDA/EMA)
• Proficiency in SAS; knowledge of R is a plus
• Strong understanding of CDISC (SDTM/ADaM) standards
• Excellent communication and stakeholder management skills