Provides leadership within biostatistics function to develop and execute statistical strategy, design and analyses for safety data across all phases.
This role can be based at Exelixis' corporate headquarters in Alameda, CA or can be a remote-based role in the U.S.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Work with the department head to develop and implement department standards and practices as they relate to clinical trial safety data and databases.
• Provides strategic direction and statistical expertise to collection, evaluation and presentation of safety data ensuring a holistic, efficient and consistent approach.
• Provides statistical input and collaborate with the Safety Department to execute statistical analyses for post authorization pharmacovigilance including signal detection and evaluation.
• Understands, identifies, develops, implements and supports the use of graphical visualization tools to evaluate aggregated and/or patient-level safety data for ongoing review.
• Contributes to the development of Drug Safety Update Reports, and Periodic Safety Update Reports Develops processes, procedures , templates, and forms to standardize the development of these reports.
• Supports internal routine safety surveillance activities/committees. Collaborates with other functional areas to develop IBs and performs safety signal evaluations.
• Defines and drives statistical strategy for safety analyses across programs ensuring acceptable statistical methodology to health authorities and scientific community, timely and accurate analyses and appropriate presentation of results.
• Reviews protocols and case report forms for soundness of trial design as it relates to safety data.
• Reviews safety sections of SAPs.
• Develops and implements biostatistics department policies, standards, practices and work-instructions in coordination with department leader and leaders in other functions.
• Provides advise and collaborates on the development, validation and summary of integrated safety summaries.
• Recruits, develops, and supervises safety statisticians. Support internal routine safety surveillance activities/committees.
• Evaluates and manages contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.
• Directly supervises employee(s).
• Indirectly supervises employee (s) through a dotted line structure or via other subordinate supervisors.
• MS/MA degree in Statistics/Biostatistics or related discipline and ten years of related experience; or,
• PhD in Statistics/Biostatistics or related discipline and eight years of related experience, or;
• Equivalent combination of education and experience.
• Managed and or supported clinical trials, preferably in oncology and in the biotech/pharmaceutical industry.
• Preferably has experience as a safety statistician.
• In-depth knowledge of CDISC standards.
• Typically requires a minimum of 16 years of related experience and/or combination of experience and education/training.
• Comprehensive and detailed knowledge of statistical experimental designs, analyses and clinical trial requirements, particularly pertaining to oncology trials.
• Developed/reviewed SDTM/ADaM specifications.
• Excellent knowledge of FDA/EU statistical guidelines as they relate to safety.
• Must have experience in state-of-the-art data organization and statistical analyses using statistical software such as: SAS and R
• Guides the successful completion of major projects by identifying and implementing appropriate techniques and evaluation criteria.
• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Has understanding of other disciplines such as data management, statistical programming, clinical operations, clinical development, regulatory affairs and drug safety.
• Project management and contract negotiation with outside vendors.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve these goals in creative and effective ways.
• Develops technical and/or business solutions to complex problems.
• Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
• Applies strong analytical and business communication skills.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.