Principal Statistician / Associate Director, Early Oncology Statistics

Employer
AbbVie
Location
Redwood City, CA, US
Posted
Sep 11, 2019
Ref
1906216
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

We have an exciting opportunity for a senior level statistician (position title commensurate with experience). There is flexibility for this position to be based at our South San Francisco (CA), Redwood City (CA), or Lake County (IL) location. In this position, you will provide scientific and statistical expertise for drug discovery or development strategies for assigned project in early-stage oncology for the design, analysis, and reporting of scientific research trials and for interacting with regulatory agencies regarding the results of these activities. Detailed responsibilities include:
Protocols:
  • Directs the development of scientific protocols, ensuring they are scientifically 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 and sound, consistent with the objective(s) of the scientific protocol
Database Activities:
  • In collaboration with Data Sciences, Statistical Programming and other partners, ensures data collection instruments are designed to capture protocol-specified scientific information and study databases (e.g., SAS, MS Access, Excel) are implemented such that short- and long-term project needs can be achieved
  • Oversees or partners in the development of data quality assurance checks, ensuring accuracy and consistency of data released for statistical analysis
Statistical Analyses:
  • Demonstrates extensive understanding of statistical concepts and methodologies
  • Proposes new/novel statistical methodological approaches leading to improvements in the efficiency and sensitivity of study results
  • Provides sufficient detail to allow programming implementation
  • Ensures that all the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately
Scientific Reports and Publications:
  • Ensures that study results and conclusions are scientifically sound, clearly presented, and supported by the statistical analyses provided
  • Prepares oral and written reports to effectively communicate 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

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. 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. 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: Mentors junior staff and other development partners with regards to statistical methodology and departmental operations
  • Participates in department seminars, short courses, and the publication presentation of scientific articles
  • 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.

  • 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. Project lead experience 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 clinical studies, including experience and understanding of drug development in the regulated environment preferred.
  • Experience in oncology is highly preferred; experience in early development (Phase 1) is highly preferred.
  • Ability demonstrating strong cross functional team work is required; must be able to work in a fast paced environment and change course when needed