DETAILS OF THE OFFER | Working place: Brain&Mind is a non-profit association created by the Paris Brain Institute, the Voir&Entendre Foundation and the FondaMental Foundation.
Missions: - 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.
- 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.
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.).
Skills: - Experience with real world evidence (RWE) studies
- Familiarity with CDISC standards
- Familiarity with clinical trial data management systems (CDMS)
- Familiarity with Software as Medical Device (SaMD)
- Familiarity with biomarker data and its applications in randomized controlled trials designs
- Experience in Python programming
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