Senior Biostatistics Manager – RWE

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November 26

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Fortrea

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Lead complex studies or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings • Lead the development of complex SAPs perform senior review of SAPs developed by other statisticians • Conduct overall statistical review of Tables Figures and Listings for complex studies prior to client delivery • Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant • Present and share knowledge at monthly team meetings and at external scientific meetings and conferences • Attend bid defense meetings • Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives.

🎯 Requirements

• Advance degree in a relevant field such as biostatistics, computer sciences, etc. (Doctoral degree preferred) • 5 or more years of solid experience of working as a Lead Biostatistician in either a biotech, CRO or pharmaceutical company • Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses; SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis • Proven professional experience with SDTMs, ADaM datasets and TFLs • Proven ability to effectively communicate statistical concepts • A good knowledge of the overall observational study process • Competence in the preparation of SAPs, analysis, and reporting • Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail.

🏖️ Benefits

• No specified benefits or perks mentioned.