Sr Research Statistician
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. 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. Together, we are striving to outsmart cancer.
General Position Summary/Purpose:
Provide, under senior staff's guidance, statistical input for designing, planning, conduct and analysis of clinical studies for a development molecule candidate. Adherence to PCYC standards, and all applicable regulations and guidelines.Key Accountabilities/Core Job Responsibilities:
Collaboration with clinical scientists on protocol design (author statistical methods section and generate study randomization)
Generate statistical analysis plan for assigned protocols (incl. Mock displays)
Assume responsibility for statistical deliverables and activities in studies with possibility of assuming responsibility for individual studies, write statistical portion of integrated clinical/statistical reports
Work with SAS programmer to develop statistical programs to perform analysis, prepare data displays, verify data accuracy and validity
Supply statistical input for NDA submissions and in response to FDA queries
Provide support for investigator publications
Review case report forms, data management plan, and monitoring plan to ensure that protocol objectives are met and project standards are maintained
Review and/or coauthor analysis file specs.
Demonstrated sound knowledge of applied statistics and biostatistics and relevant experience in the application of statistics to medical /clinical trials. Experience with SAS. Strong interpersonal and effective written and verbal communication skills
Pharmaceutical industry experience is preferred. NDA submission experience and global submission experience is a plus
Experience in biomarker/genomic data analyses and excellent R programming experiences is preferred.
- Ph.D. in Biostatistics or equivalent 0-2 years' experience, or a Mater degree in Statistics/Biostatistics or equivalent with 4-6 years' experience in pharmaceutical and biotech industry.
- Ph.D. in Statistics/Biostatistics is preferred. Master degree in Statistics/Biostatistics or related area.