121 Oyster Point Blvd South San Francisco, CA 94080
Serves as a study statistician for Phase 1 or 2 studies on the study teams.
Represents Biostatistics in study team meetings. Develops Statistical Analysis Plans, creates mock-ups for tables, listings, and figures; ensures cross-functional review of those documents is conducted and comments are adjudicated and incorporated as appropriate
Collaborates with statistical programming to ensure appropriate datasets development and outputs generation.
Reviews tables, listings, and figures produced by statistical programming according to the specifications to ensure accuracy and validity of results. Provides input on study design, review protocols and author statistical section of a protocol.
Reviews clinical study reports to ensure accuracy and consistency in data presentation, data interpretation statistically sound.
Provides statistical analyses support to publications (e.g. abstracts, presentations and posters, manuscripts), reviews publications to ensure accuracy and consistency in data presentation, and data interpretation statistically sound.
Develop statistical programs as necessary to perform exploratory analyses.
Experience applying statistical methods to drug development and clinical trials Understanding of regulatory guidelines in a pharmaceutical research setting
Excellent communication skills and ability to consistently meet company urgent deliverables
Strong implementation skills
PhD or MS in Statistics/Biostatistics with prior experience in biotech/pharma industry as a statistician
Hematology oncology drug development experience is highly preferred
Proficient in SAS and/or R programming
Experience with early development studies is desirable