Senior Manager, Clinical Statistics
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, 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. This position will be based at our Redwood City, CA location.
Provide statistical support for development strategy for clinical or scientific research programs. Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Protocols: Ensures consistency among protocols within a project, and provides certification for the protocol review check list. Works with project team to select an appropriate study design to meet study objectives, contributes to decisions regarding data collection instruments. Conducts comprehensive review of protocol to ensure quality. Responsible for conducting research and identifying key parameters for sample size estimation. Independently determine appropriate statistical methodology needed in support of study objectives; develops and authors the statistical methods section of the protocol. Responsible for randomization for routine and non-routine studies. Works with external partners, including contract research organizations, drug supply, and other groups, to effectively implement the randomization schedule as planned.
Database Activities: Actively participates in meetings to identify scientifically appropriate data collection instruments and database design requirements (e.g., SAS, MS Access, Excel) to ensure that the data evaluated are free of bias, contain maximum information (minimum variance), and satisfy analysis requirements.
Statistical Analyses: Demonstrates extended understanding of statistical concepts and methodologies. Demonstrates ability to apply statistical knowledge to solve real-world problems. Demonstrates the ability to evaluate alternative statistical approaches, to make recommendations based on sound statistical reasoning, and to influence non-statisticians to accept the analytical approach. Develops analysis plans, ensuring statistical methods and corresponding details are appropriate and sound, consistent with protocol study design, and
sufficiently detailed for programming implementation. Ensures internal consistency of analysis plans for assigned studies/projects. Analyzes data from clinical trials or scientific experiments to meet objectives of the study protocol. Independently applied and implements basic and complex statistical methodology to analyses. Reviews identified or anticipated technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research. Approves and implements alternative analysis strategies or other recommendations to address these issues. Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
Scientific Reports and Publications: Works with project team to develop strategy for data presentation and scientific arguments. Ensures consistency of data presentations and scientific/statistical arguments among reports within a project. Responsible for statistical methods and relevant sections for major deliverables such as protocols, analysis plans, study reports and scientific publications. Responsible for accurate interpretation of analysis results. Responsible for high quality deliverables. Prepares oral and written reports that effectively communicate results of scientific research to the project team, AbbVie management, regulatory agencies, or individual investigators. Responsible for consistency between deliverables for the same compound and/or within same therapeutic area. Responsible for accuracy and internal consistency of report of publication, including text, tables, listings, and figures. Ensures as applicable that guidance and template format for protocol, analysis plan, and study report are closely followed. Performs peer review for protocol, analysis plan, study report, and other major deliverables, publications. Provides critical review to enhance quality of data presentation and scientific/statistical arguments. Responsible for providing critical review to enhance quality and accuracy of data presentation and scientific/statistical arguments.
Consultation: Works collaboratively with members of multi-function teams to complete project deliverables per agreed timelines. Keeps management informed on important scientific/statistical issues that may arise, in a timely manner. Provides responses to routine and non-routine questions from clients, and independently pursues analyses suggested by the data. In collaboration with Statistical Programming or their designee, ensures that all programs meet analysis requirements, internal standard operating procedures, validation, and external regulatory requirements. Communicates with statisticians outside AbbVie concerning technical issues, building external scientific contacts, fostering professional development, and promoting the reputation of the department. Responsible for developing and maintaining good client relationships. Effectively and persuasively presents statistical concepts, evidence, assessment of risks and impacts, and logical arguments to management, regulatory agencies, and scientists. Demonstrates an understanding of drug development principles for assigned projects.
Project Team Involvement: Represents Data and Statistical Sciences (DSS) or Biometrics on assigned project team(s) to provide functional area input to compound/drug development. Serves as a liaison between the project team and DSS or Biometrics to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional area.
Training, Supervising, Mentoring: Maintains technical skills and increases own knowledge of new statistical methodology or areas of application through use of the scientific literature and attendance at professional meetings. Presents own statistical research or review of the statistical literature at meetings and seminars. Demonstrates a high degree of responsibility in maintaining Statistics / Biometrics department standards, GxP compliance, and best operating practices. Participates in departmental activities including recruiting, training/mentoring, research efforts, and cross-functional collaborations, as needed.
Regulatory Activities: Participates with DSS or Biometrics management in discussions with corresponding technical personnel from regulatory agencies and with investigators concerning proposed or ongoing studies.
- Senior Manager: PhD in statistics or related field with 4-6 years or MS in statistics or related field with 8-10 years of work experience in pharmaceutical development and applied statistics/statistical consulting required
- Principal Statistician: PhD in statistics or related field with 8-10 years or MS in statistics or related field with 12 years of work experience in pharmaceutical development and applied statistics/statistical consulting required
- High degree of technical competence and effective oral and written communication skills.
- Competent in experimental design, statistical modeling and inferential statistics; actively seeks to acquire knowledge concerning the use of new/novel statistical techniques and their biometric/ biopharmaceutical applications.
- Pharmaceutical or related industry experience with nonclinical, clinical or pharmacology studies, as appropriate, including experience and understanding of drug development in the regulated environment preferred.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled