Manager, Statistics (Job code:TB230), Abbott Biotherapeutics Corp., Redwood City, CA
Job Description:
Provide statistical support for clinical programs including protocol design, SAP development, and clinical trial reporting.
For protocols, with project team select appropriate study design, ensure consistency with other protocols, identify key parameters for sample size, responsible for sample size estimation, and oversee statistical analysis section.
Ensure clarity, accuracy and consistency of CRFs, database definitions, and specifications for analysis files for individual studies; ensure consistency across studies within a project.
Develop SAPs for routine and non-routine studies.
Provide input to development of strategy for data presentation, responsible for statistical and relevant sections for major deliverables, responsible for accurate interpretation of analysis results, responsible for high quality deliverables.
Demonstrates extensive knowledge of statistical concepts & methodologies related to the pharmaceutical industry. Demonstrate ability to apply advanced technique to solve problems, ability to evaluate alternative statistical approaches, to recommend one with sound reasoning, and to influence non-statistician colleagues to accept the analytical approach.
Work collaboratively with multi-function teams to provide statistical support per timelines. Work effectively with partners.
Represent statistics, programming, and data management in assigned global project team to provide function input to compound development.
Be compliant with training requirements. Effectively mentors less experienced statisticians. As project lead, coordinates activities of statisticians and programmers, and reviewing deliverables to ensure quality and speed.
Qualification: MS or Ph.D in (Bio)statistics with a minimum of 6+ years (PhD) or 12+ years (MS) experience in pharmaceutical industry with solid oncology experience, strong technical skills, and strong verbal and written communication skills, a thorough knowledge of the drug development process, experience with submitting and supporting regulatory agency review of international registration packages and thorough understanding of ICH Guideline and relevant regulatory requirements, and a good understanding of SAS and/or SPLUS.
Contact: Carrie Dunn, Phone: 847-935-0632 or Email: carrie.dunn@abbott.com