ClinChoice - Senior statistician Consultant- V&I (Vaccines & Infectious Diseases)
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 • Vaccines & Infectious Diseases • In-depth knowledge of clinical trial methodology and statistical principles • Experience with regulatory submissions (FDA/EMA) • regulatory submissions (FDA/EMA) • Proficiency in SAS; knowledge of R is a plus • Strong understanding of CDISC (SDTM/ADaM) standards • CDISC (SDTM/ADaM) • 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? • 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 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.
Responsibilities
• Lead statistical input for clinical trial design, including protocol development and sample size calculations • Develop and review Statistical Analysis Plans (SAPs) • 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 • CDISC standards • Participate in safety and efficacy analyses, including interim analyses • Provide strategic input for ISS/ISE and integrated analyses
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