[Hiring] Senior Statistician Consultant @ClinChoice

Role Description

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

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

Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.