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Proclinical Staffing

Sr. Manager-AD, Biostatistics

Proclinical Staffing, San Francisco, California, United States, 94199


Senior Manager-AD Biostatistics

- Permanent - San Francisco Bay, CA

Please make an application promptly if you are a good match for this role due to high levels of interest.Proclinical is seeking a dedicated and experienced individual for the role of Senior Manager - Associate Director, Biostatistics.Primary Responsibilities:Lead the statistical strategy and execution across multiple development programs, collaborating with various teams to design and execute clinical trials.Manage external statisticians and statistical programmers, ensuring the highest standards of quality and compliance in all statistical components of clinical studies.Skills & Requirements:Ph.D. in Statistics, Biostatistics, Mathematics, or a related field.Working experience in clinical trial development.Proven history of managing the delivery of statistical projects by external CROs.Deep knowledge of industry regulations.Excellent communication skills.Ability to collaborate well with teams as well as being able to work independently when required.Additional Responsibilities:Collaborate with various teams on the design and execution of clinical trials.Oversee the statistical components of clinical studies managed by external parties, ensuring timely and quality delivery of analysis results.Work closely with Statistical Programming to generate and validate statistical analyses for both internal and external presentations.Ensure CDISC electronic data packages meet completeness, regulatory standards, and submission readiness.Stay informed on the latest regulatory requirements and scientific advancements in statistical methods for clinical trials.Consult with internal audit teams to assess the regulatory compliance of external parties concerning statistical SOPs.Contribute to the governance and development of biostatistical SOPs, ensuring best practices across the organization.

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