AbbVie Manager, Early Oncology Statistics in South San Francisco, California
Manager, Early Oncology Statistics
USA, California, South San Francisco
2 additional locations
USA, Illinois, Lake CountyUSA, California, Redwood City
Research & Development
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.
We have an opportunity for a Manager, Statistics reporting to Director, Statistics. This position will be based at AbbVie's South San Francisco, CA location. In this position, you will provide statistical expertise for drug discovery or development strategies for assigned project in early-stage oncology for design, analysis, and reporting of clinical trials or other scientific research.
Develops statistical methods and other relevant sections of major deliverables such as protocols, analysis plans, study reports and scientific publications
Contributes to decision making on study design and data collection, ensuring alignment with study objectives.
Develops statistical methods and other relevant sections of major deliverables such as protocols, analysis plans, study reports and scientific publications.
Protocols: Ensures consistency among protocols within a project and provides certification for the protocol review check list. Conducts comprehensive review of protocol to ensure quality.
Database Activities: Actively participates in meetings to identify scientifically appropriate data collection instruments and database design requirements to ensure that the data evaluated are free of bias, contains maximum information, and satisfy analysis requirements.
Statistical Analyses: Develops analysis plans, ensuring statistical methods and corresponding details are appropriate and sound, consistent with the study design, and sufficiently detailed for programming implementation. Ensures internal consistency of analysis plans for assigned studies/projects.
Scientific Reports and Publications: Works with project team to develop strategy for data presentation and scientific/statistical arguments.
Prepares oral and written reports to effectively communicate results of clinical/scientific research to AbbVie management, project teams, regulatory agencies, or individual investigators.
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.
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.
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.
MS or PhD in Statistics, Biostatistics, or a highly related field with at least 2-4 years (PhD) or 6-8 years (MS) of experience in pharmaceutical development and applied statistics/statistical consulting required.
Must have comprehensive knowledge of applied statistical principles and modeling in drug research and development, and proficiency in statistical software such as SAS and R. Must have excellent interpersonal and effective verbal and written communication skills.
Builds a learning environment and is open to suggestions and experimentation for improvement. Accepts the ideas of others, cultivates innovation and manages innovation to reality
Strong leadership skills and experience in managing a programming group.Experience in working/managing in an international team
Builds positive relationships with peers and cross functionally with partners outside of team to enable higher performance. Raises the bar and is never satisfied with the status quo.
Proficient in experimental design, descriptive and inferential statistics, biometrics biopharmaceutical applications and computer programming
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
Learns fast, grasps the 'essence' and can change the course quickly where indicated.
Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced