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

About this role

<p></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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….</span></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">ClinChoice is searching for an <strong>Senior Biostatistician Consultant </strong>to join one of our clients in <strong>V&I (Vaccines & Infectious disease ) department </strong></span><br><br></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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.  </span></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"></span></p> <h2 style="line-height: 1.2;" data-section-id="1dngq08" data-start="345" data-end="366"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong data-start="348" data-end="366">Role Overview:</strong></span></h2> <p style="line-height: 1.2;" data-start="367" data-end="705"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">We are seeking an experienced <strong data-start="397" data-end="431">Senior Statistician Consultant</strong> to support clinical development programs within the <strong data-start="484" data-end="524">Vaccines & Infectious Diseases (V&I)</strong> therapeutic area. The role involves leading statistical strategy, analysis, and reporting for clinical trials, ensuring high-quality deliverables aligned with regulatory standards.</span></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"></span></p> <h2 style="line-height: 1.2;" data-section-id="1kmydoi" data-start="712" data-end="740"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong data-start="715" data-end="740">Key Responsibilities:</strong></span></h2> <ul data-start="741" data-end="1552"> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="7s560f" data-start="741" data-end="854"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Lead statistical input for clinical trial design, including protocol development and sample size calculations</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="7zdmsh" data-start="855" data-end="915"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Develop and review <strong data-start="876" data-end="913">Statistical Analysis Plans (SAPs)</strong></span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="1hzazfy" data-start="916" data-end="995"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Provide oversight of statistical analyses for clinical studies (Phase I–IV)</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="1wfrd19" data-start="996" data-end="1092"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Collaborate with cross-functional teams including Clinical, Data Management, and Programming</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="1swo37g" data-start="1093" data-end="1168"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Interpret study results and contribute to clinical study reports (CSRs)</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="wfh48u" data-start="1169" data-end="1268"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Support regulatory submissions (e.g., FDA, EMA) including responses to health authority queries</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="1k3lhc5" data-start="1269" data-end="1339"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Guide and review work of statistical programmers (SDTM/ADaM, TLFs)</span></li> <li style="font-family: tahoma, arial,…