BIOSTATISTICIAN WITH CLINICAL TRIALS (REMOTE) Project Description:
SOUTH SAN FRANCISCO, CA
The Biostatistician is responsible for the quality and timely statistical support to the assigned tasks under the supervision of the biostatistics Director.
- 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.
- Provide statistical consultation on PK/PD and biomarkers analyses in clinical and pre-clinical studies.
- 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 PK/PD analysis is desirable.
- 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.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: URL blocked - click to apply
ALPHA'S REQUIREMENT #19-01610
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE