Sr. Manager-AD, Biostatistics

Senior Manager-AD Biostatistics - Permanent - San Francisco Bay, CA

Proclinical is seeking a dedicated and experienced individual for the role of Senior Manager - Associate Director, Biostatistics.

Primary Responsibilities:

The successful candidate will lead the statistical strategy and execution across multiple development programs, collaborating with various teams to design and execute clinical trials. This role also involves managing 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.

The Senior Manager, AD for Biostatistics' responsibilities will be:

• 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.

If you are having difficulty in applying or if you have any questions, please contact Jennifer Iantosca at (+1) 917-475-4588 or j.iantosca@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.