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

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for an Senior Biostatistician Consultant to join one of our clients in V&I (Vaccines & Infectious disease ) department

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Role Overview:

We are seeking an experienced Senior Statistician Consultant to support clinical development programs within the Vaccines & Infectious Diseases (V&I) therapeutic area. The role involves leading statistical strategy, analysis, and reporting for clinical trials, ensuring high-quality deliverables aligned with regulatory standards.

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:

• <span style="font-family: tahoma, arial, helvetica,