Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.
AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, statisticians, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. We have an exciting opportunity of Director, Biostatistics. This position will be based in the Bay Area of California, or in North Chicago, IL, and co-located with the scientific collaborators.
The Director of Biostatistics will be responsible for leading and directing the statistical strategy for the oncology portfolio of the West Coast, which comprises of Stemcentrx and AbbVie Biotherapeutics. Through own efforts and those of their staff, the Director provides scientific and statistical input for clinical development plans; for the design, analysis, and reporting of clinical trials; and for interacting with regulatory agencies regarding the results of these activities.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Ensures scientific protocols are scientifically and statistically sound and make optimal use of the data to be collected. Ensures research hypotheses and corresponding study designs are aligned with the project strategy, and meet scientific and/or regulatory needs. Ensures statistical methodology is appropriate, consistent with the objective(s) of the scientific protocol.
In collaboration with Data Sciences, Statistical Programming and other stakeholders, ensures data collection instruments are designed to capture protocol-specified scientific information and study databases are implemented such that short- and long-term project needs can be achieved. Oversees or partners in development of data quality assurance checks, ensuring accuracy and consistency of data released for statistical analysis.
Demonstrates outstanding understanding of statistical concepts and methodologies. Takes a leadership role in introducing new/novel statistical methodological approaches into analysis plans which improve the efficiency and sensitivity of study results. Ensures that all the statistical analyses specified in the scientific protocols and/or analysis plans are conducted appropriately.
Ensures that study results and conclusions are scientifically sound, clearly presented, and supported by the statistical analyses provided. Communicates effectively results of clinical/scientific research to AbbVie management, project teams, regulatory agencies, or individual investigators. Provides in-depth scientific/statistical review for scientific reports and publications. Ensures the accuracy of the statistical component of scientific reports and/or publications with high quality.
Works collaboratively with multiple stakeholders to develop scientifically appropriate development strategies per agreed timelines and ensures appropriate functional representation to the teams. When needed, represents statistics, programming, and data management in assigned Asset Development Teams (ADT's) to provide functional area input to compound development. Ensures that clinical development program incorporates sufficient statistical and scientific rigor and quality to meet stated objectives and global regulatory needs, and ensures alignment with functional management.
Demonstrates an accurate understanding and implementation of current regulatory requirements and issues that could affect the design, conduct, analysis, or interpretation of clinical programs. Effectively and persuasively presents statistical concepts, evidence, logical arguments and emerging regulatory trends to management, regulatory agencies, scientists and a broad range of stakeholders. Critically reviews the regulatory submission documents for projects in therapeutic areas outside his/her direct control, as requested by management.
Responsible for allocating resources within the group, including accurate prediction of future workloads and the ability to maximize statistical productivity within the group, and work effectively with other functional areas. Has budgetary responsibility for assigned area(s), and is responsible for recruiting high caliber statisticians to the department.
Provides coaching and mentoring to first line managers when needed. Ensures continuous development of staff through internal and external training opportunities. Gain expertise on and provide training on innovative methods to staff when necessary. Responsible for providing strong professional and technical leadership to maintain a highly motivated staff. Ensures that self and staff are compliant with training requirements.
Ph.D. in Statistics, Biostatistics or a related field.
Minimum of 12 years (Ph.D) experience in pharmaceutical development and applied statistics leading at least two NDA, BLA, and/or CTD submissions. A minimum of 3 years management experience.
High degree of technical competence and communication ability, both oral and written. Highly competent in experimental design, descriptive and inferential statistics, and computer systems, especially in medical applications.
Pharmaceutical or related industry experience with clinical trials, including interaction with regulatory agencies. Knowledge of the guidelines of worldwide regulatory agencies; the ability to lead and advise the ADT's and other scientists in the methodology and design of clinical studies.
Understands the medical, scientific, operational, regulatory, and technological problems of a therapeutic area and global implications of statistical strategies, relates these to the internal and external statistical requirements for the project, and directs the implementation of statistical strategies to appropriately address these requirements. Balances the short-term needs of projects with the long-term development of the statistical function.
At AbbVie, we have the expertise of a proven pharmaceutical leader and the focus and passion of an entrepreneur and innovator. The result is something rare in health care today – a global biopharmaceutical company that has the ability to discover and advance innovative therapies and meet the health needs of people and societies around the globe.