Head of Biostatistical Research

2 weeks ago

California, United States Meet Full time

Position: Director of Biostatistics

Location: San Francisco Bay Area, CA

Our client is an innovative biotechnology firm focused on developing groundbreaking therapies for oncology. Their mission is to revolutionize treatment for cancer and autoimmune diseases through advanced research and development initiatives. This organization is a vibrant and expanding entity that operates in a hybrid work environment.

*Relocation assistance and visa transfers are available

Key Responsibilities:

  • Guide and support a team of biostatisticians, offering strategic leadership and ensuring the delivery of high-quality statistical assistance across all clinical projects.
  • Engage with cross-functional teams, including clinical development, regulatory affairs, and data management, to formulate and execute statistical strategies that align with the organization's goals.
  • Supervise the design, execution, and analysis of clinical trials, ensuring the application of appropriate statistical methodologies to satisfy regulatory and scientific standards.
  • Draft and evaluate statistical analysis plans (SAPs), ensuring precise execution of statistical evaluations and interpretation of outcomes.
  • Provide statistical guidance and support for regulatory submissions, including the preparation and review of statistical components in regulatory documents (e.g., INDs, NDAs, and BLAs).
  • Effectively communicate intricate statistical concepts and results to non-statistical stakeholders, including senior management and regulatory bodies.
  • Collaborate closely with research and development teams to design and assess innovative methodologies and statistical approaches for clinical trials.
  • Remain informed about advancements in biostatistics and oncology, integrating new methodologies and technologies to improve the quality and efficiency of statistical analyses.

Qualifications:

  • Ph.D. or Master's degree in Biostatistics, Statistics, or a related discipline is preferred.
  • A minimum of 8 years of experience in biostatistics, with substantial experience in oncology or autoimmune clinical trials and drug development is essential.
  • Demonstrated leadership and team management experience in a biotechnology or pharmaceutical environment.
  • Strong proficiency in statistical methods, including survival analysis, longitudinal data analysis, and adaptive trial designs.
  • Expertise in statistical software (e.g., SAS, R, or similar tools).
  • Exceptional communication skills, with the capability to present complex statistical information to varied audiences.
  • Proven ability to work collaboratively in a dynamic, multi-disciplinary setting.

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