Biostatistician Technical Expert - Clinical Statistics

Main responsibilities: Support the clinical development plan (CDP), clinical study design (including protocol development and review), the study setup and conduct. Conduct / Oversee the execution of the statistical analyses according to the SAP and ISAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs. Serve as a biostatistical consultant for other members of the department and staff members from other statistics department within the organization. Provide mentoring and coaching advanced statistical methodologies to junior statisticians in Hub. Maintain knowledge and awareness of development in biostatistics and clinical trial methodology and regulatory requirements that impact on analysis. Accountable for all assigned statistical deliverables related to multiple studies or specific domains: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, Estimands etc., SAP, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables). Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives. Contribute to define and review the specific deliverables related to Transparency and Disclosure. Coordinate with study programmer the production and Qc of statistical analyses. Contribute to operation process optimization and provide inputs to statistics and quality standards. Represent statistics team to participate in scientific or technology working groups or cross function initiatives. undefined Experience : (MS) or (PhD) of solid pharmaceutical industry experiences. Experience of project management and development preferred. Soft and technical skills : Broad knowledge and good understanding of advanced statistical concepts and techniques Demonstrated strong project/study management, interpersonal and communication skills. Good knowledge of pharmaceutical clinical development, together with early, late phase and post-marketing experiences Extensive ability to apply advanced statistical analyses using SAS and R languages. Knowledge or experience with Artificial intelligence or Generative AI is a plus Education : MS or PhD degree in Statistics or relevant fields Languages : Highly effective communication in English, both oral and written. Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !