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

United States

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: 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 The 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 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. Who will you be working for? 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. Our 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 and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the 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 have based 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. #LI-TT1 #LI-Remote #Senior#Contract