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 with a global CRO can bring? Our team says it’s the best of both worlds.

About the role

We are seeking an experienced Senior Biostatistician 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.

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

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

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built. Close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry-average turnover rates.

ClinChoice is an equal opportunity employer. We base our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.