Job Title: Associate Director, Biostatistics Late Stage (Oncology)
Salary: $180k-220k base + bonus + benefits
Job Summary: The Associate Director of Biostatistics in Oncology will provide strategic and technical leadership in the design, analysis, and interpretation of clinical trials in oncology. This role will collaborate with cross-functional teams to ensure the statistical integrity and scientific validity of clinical studies. The Associate Director will also contribute to regulatory submissions and the development of innovative statistical methodologies.
Key Responsibilities:
Lead the statistical design and analysis of oncology clinical trials, ensuring robust and scientifically sound methodologies.
Collaborate with clinical development, regulatory affairs, and other departments to develop clinical trial protocols and statistical analysis plans.
Provide statistical expertise for regulatory submissions, including preparation of statistical sections of INDs, NDAs, and other regulatory documents.
Oversee the development and validation of statistical models and methodologies for oncology studies.
Ensure compliance with regulatory requirements, Good Clinical Practice (GCP), and Standard Operating Procedures (SOPs).
Review and approve statistical deliverables, including analysis datasets, tables, listings, and figures.
Participate in the selection and management of biostatistics vendors and contractors.
Stay current with advancements in statistical methodologies with oncology late stage research, incorporating new techniques as appropriate.
Present statistical findings to internal and external stakeholders, including regulatory agencies and scientific conferences.
Qualifications:
Ph.D. or Master's degree in biostatistics, statistics, or a related field.
Minimum of 5 years of experience in biostatistics, with at least 3 years in a Study/Project leadership role within oncology late stage expertise.
Vendor Management Oversight experience
Strong knowledge of clinical trial design, statistical analysis, and regulatory requirements in oncology.
Proficiency in statistical software (e.g., SAS, R)
Excellent organizational, communication, and leadership skills.
Ability to work collaboratively in a fast-paced, dynamic environment.
Detail-oriented with strong problem-solving and analytical skills.
Preferred Qualifications:
Experience with global clinical trials and regulatory submissions (FDA, EMA)
Knowledge of CDISC standards (SDTM, ADaM).
Experience with adaptive trial designs and Bayesian methodologies.