Senior statistician Consultant- V&I (Vaccines & Infectious Diseases)
About The Position
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. 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.
Requirements
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
