Senior Biostatistics Manager

1 week ago

California, United States Proclinical Staffing Full time

Senior Biostatistics Manager - Permanent Position

Proclinical Staffing is in search of a skilled and knowledgeable professional for the position of Senior Biostatistics Manager.

Key Responsibilities:

The ideal candidate will be responsible for steering the statistical strategy and implementation across various development initiatives, working in collaboration with diverse teams to design and carry out clinical trials. This position also entails overseeing external statisticians and statistical programmers, guaranteeing the utmost quality and compliance in all statistical elements of clinical research.

Qualifications & Expertise:

  • Ph.D. in Statistics, Biostatistics, Mathematics, or a closely related discipline.
  • Experience in the development of clinical trials.
  • Demonstrated success in managing statistical project delivery through external Contract Research Organizations (CROs).
  • Thorough understanding of industry regulations.
  • Exceptional communication abilities.
  • Capacity to work collaboratively within teams while also being capable of independent work when necessary.

Responsibilities of the Senior Biostatistics Manager include:

  • Collaborating with various teams to design and implement clinical trials.
  • Supervising the statistical aspects of clinical studies conducted by external parties, ensuring timely and high-quality delivery of analytical results.
  • Working closely with Statistical Programming to produce and validate statistical analyses for both internal and external presentations.
  • Ensuring that CDISC electronic data packages meet completeness, regulatory standards, and are ready for submission.
  • Keeping abreast of the latest regulatory requirements and scientific advancements in statistical methodologies for clinical trials.
  • Consulting with internal audit teams to evaluate the regulatory compliance of external parties concerning statistical Standard Operating Procedures (SOPs).
  • Contributing to the governance and development of biostatistical SOPs, ensuring best practices are upheld across the organization.

Proclinical Staffing 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.

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