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Stefanini Group is hiring for a Sr. Biostatistician. Exciting opportunity awaits! Let us help you get started. Call Aditya Yadav - (/ Summary:Responsible for study-level statistical expertise. Essential Duties and Responsibilities: Represent Statistics function in study team meetings. Author and/or provide input on statistical sections of clinical study documents including protocols, electronic case report forms, randomization plans, data transfer specifications, statistical analysis plans, tables, listings, and figures (TLF) shells, SDTM/ADaM specifications, clinical study reports, and other relevant documents. Drive TLF development and TLF reviews with programming and other relevant team members, determine analysis populations, validate key analysis results, and present final analysis results to key stakeholders. May be accountable for five or more concurrent clinical studies.
Qualifications: Proficiency in SAS and knowledge of CDISC standards. Strong working knowledge of statistical data analysis and data management principles. Knowledge of clinical trial methodology and study design. General project management skills. Good oral and written communication. Good collaborative skills and ability to work with a cross-functional team.Education and/or Experience:Masters/PhD in StatisticsMinimum of 3-5 years recent related clinical experienceExperience with different clinical phasesClinical experience in a regulated environment and organization fit are the keys things the manager needs for the team.