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Biostatistician with Clinical Trials (Remote)

Alpha Consulting South San Francisco Contractor
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 BIOSTATISTICIAN WITH CLINICAL TRIALS (REMOTE)
SOUTH SAN FRANCISCO, CA
 
 
Project Description:
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. 
 
Required 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 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

#ZR
 

Recommended skills

Clinical Study Reports
Drug Development
Clinical Trials
Data Analysis
Clinical Study Design
Biotechnology
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Job ID: 19-01610

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