Lead Biostatistician – Neurosciences Clinical Trials

About the job Job Overview: We are seeking a highly motivated and skilled Lead Biostatistician with a strong background in early-phase clinical trials to join our dynamic and innovative team. Reporting to the Head of Clinical Programs, this on-site position based in Paris requires m ore than 8 years of experience in statistics applied to clinical trials, including industry experience . The successful candidate will be agile and adaptable, capable of working in a face-paced, innovative start-up environment where collaboration across Clinical Development, Programming, and Statistics is essential. Whilst an excellent track record in clinical trial design is a must, the successful candidate will also contribute to Real World Evidence (RWE) studies in both drug and medical device . Key Responsibilities : Participate in the conception and design of Randomized Controlled Trials , providing expert statistical support including study design, sample size determination, definition of study objectives and estimates, writing the statistical section of the protocol and development of the statistical analysis plan. Have a strong understanding of clinical trial design and methodology with substantial knowledge in the following: Bayesian, Adaptive Designs, Basket / Umbrella / Platform Trial, Multiple-Testing Adjustment, Small Populations, Individualized Treatment Effects. Act as the primary point of contact internally and externally for all statistical aspects of assigned projects and studies, attending project/study meetings and offering statistical guidance. Draft and/or validate key study documents such as synopses, protocols, CRFs, data review plans, statistical analysis plans, statistical results, study reports and other study-level documents while ensuring timely deliverables. Program and/or validate statistical analyses using SAS software . Collaborate with the Head of Clinical Programs to interpret results, develop key messages, and communicate findings to clinical, academic and regulatory partners . Work with internal clinical leadership to prepare Response to Questions from regulatory agencies (EMA / FDA / PMDA / …), summaries of results for regulatory documents and scientific articles Oversee the review of statistical documents within the team and assist in the supervision of operational activities outsourced to CROs ensuring adherence to cost, timeline, and data quality requirements Participate in the strategy of submission dossier to FDA and EMA. Coordinate production of Safety and Efficacy integrated pool and related statistical analyses. Follow all industry standards, including ensuring that all statistical related documentation is included in the electronic Trial Master File (eTMF). Job Type: Full-Time (hybrid) – on site in Central Paris and possibility of working from home up to 2 days per week The Successful Applicant Qualifications: Advanced degree in Statistics (Master's Degree, ENSAI, ISUP, or PhD) or a related field. A minimum of 8 years of experience in the pharmaceutical industry or a Contract Research Organization ( CRO ), with significant involvement in clinical trial development from the outset in both drug and medical device studies. Strong experience in neurology, neuroscience, neuro-oncology or psychiatric clinical trial design is highly desirable. Advanced statistical analysis skills. Proficiency in at least one of the following two statistical software: SAS or R. Strong knowledge of international scientific and regulatory guidelines (ICH, EMA, FDA, etc.). Good written and verbal communication skills in English and French. Excellent communication and cooperation skills, with a rigorous and pragmatic approach. Creativity, proactivity, rigor, autonomy, and collaborative spirit. Strong ability to manage multiple studies simultaneously and maintain organization. Preferred Skills: Experience with real world evidence (RWE) studies Familiarity with CDISC standards Familiarity with clinical trial data management systems (CTMS) Familiarity with Software as Medical Device (SaMD) Familiarity with biomarker data and its applications in randomized controlled trials designs Experience in Python programming What's On Offer When you join the Brain&Mind team, you'll benefit from : the dynamism and pioneering spirit of a growing team The opportunity to be at the heart of tomorrow's challenges, with the support of a major government investment and the active involvement of major industrial players. Trust, autonomy and budget Protection and benefits at the highest level The ability to see the positive impact of your actions on a daily basis About Brain&Mind Brain&Mind is a non-profit association created by the Paris Brain Institute, the Voir&Entendre Foundation and the FondaMental Foundation. It is the operator of the Brain&Mind Biocluster, endowed by the French government with an initial investment of €100 million over the period 2024-2034, with the aim of accelerating innovation in the field of neuroscience (neurology, psychiatry, sensory deficiencies). Brain&Mind has set up a team of experts in the fields of drugs, medical technologies and digital health in Paris, and will promote the deployment of new products and services in the field of brain disease. Start-ups, investors, manufacturers, universities and major hospitals are all involved in the project, such as major research institutes in the Paris region and patient associations.

Location: Paris, FR

Posted Date: 1/21/2025