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

<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&nbsp;<strong>Senior Biostatistician Consultant&nbsp;</strong>to join one of our clients in <strong>V&amp;I (Vaccines &amp; Infectious disease ) department&nbsp;</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.&nbsp;&nbsp;</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 &amp; Infectious Diseases (V&amp;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, helvetica, sans-serif; font-size: 12pt;" data-section-id="1jhs4a7" data-start="1340" data-end="1412"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Ensure compliance with <strong data-start="1365" data-end="1384">CDISC standards</strong> and regulatory guidelines</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="iqs4ct" data-start="1413" data-end="1488"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Participate in safety and efficacy analyses, including interim analyses</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="f5mtvp" data-start="1489" data-end="1552"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Provide strategic input for ISS/ISE and integrated analyses</span></li> </ul> <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="10rmqdw" data-start="1559" data-end="1590"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong data-start="1562" data-end="1590">Required Qualifications:</strong></span></h2> <ul data-start="1591" data-end="2093"> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="116dm4" data-start="1591" data-end="1657"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Master’s or PhD in Statistics, Biostatistics, or related field</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="1x6lsre" data-start="1658" data-end="1721"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">5+ years of experience in clinical trials within pharma/CRO</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="9injda" data-start="1722" data-end="1781"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Strong experience in <strong data-start="1745" data-end="1779">Vaccines &amp; Infectious Diseases</strong></span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="11xw0g1" data-start="1782" data-end="1861"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">In-depth knowledge of clinical trial methodology and statistical principles</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="iqo91v" data-start="1862" data-end="1918"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Experience with <strong data-start="1880" data-end="1916">regulatory submissions (FDA/EMA)</strong></span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="1r91vwk" data-start="1919" data-end="1971"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Proficiency in <strong data-start="1936" data-end="1943">SAS</strong>; knowledge of R is a plus</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="137scjt" data-start="1972" data-end="2031"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Strong understanding of <strong data-start="1998" data-end="2019">CDISC (SDTM/ADaM)</strong> standards</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-section-id="19l0wna" data-start="2032" data-end="2093"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Excellent communication and stakeholder management skills</span></li> </ul> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"></span></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>The Application Process</strong></span></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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.&nbsp; Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.</span></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Who will you be working for?</strong></span></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>About ClinChoice</strong></span></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 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.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Our Company Ethos</strong></span></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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.&nbsp;&nbsp; The success of these core values is evidenced by our below industry average turnover rates.</span></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p> <p style="line-height: 1.2;"><span class="ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak" style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong><br><span data-teams="true">#LI-TT1 #LI-Remote #Senior#Contract</span></strong></span></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"></span></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"></span></p>