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Senior Biostatistics Manager

2 months ago

California, United States Proclinical Staffing Full time

Senior Biostatistics Manager - Permanent Position

Proclinical Staffing is seeking a highly skilled and experienced professional for the position of Senior Biostatistics Manager.

Key Responsibilities:

The ideal candidate will be responsible for directing the statistical approach and implementation across various development initiatives, working collaboratively with multiple teams to design and conduct clinical trials. This position also entails overseeing external statisticians and statistical programmers, ensuring that all statistical elements of clinical studies adhere to the highest standards of quality and compliance.

Qualifications & Skills:

  • 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 effectively within teams as well as independently when necessary.

Responsibilities of the Senior Biostatistics Manager include:

  • Collaborating with diverse teams on the design and execution of clinical trials.
  • Supervising the statistical aspects of clinical studies conducted by external entities, 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 reporting.
  • Ensuring that CDISC electronic data packages meet completeness, regulatory standards, and readiness 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 regarding statistical standard operating procedures (SOPs).
  • Contributing to the governance and development of biostatistical SOPs, ensuring best practices throughout 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.