Sr. Biostatistician

San Francisco, California | Contract

Post Date: 09/19/2017 Job ID: 3330 Industry: Research

Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients. 

 

Duties:
  • Provides statistical input into Phase I - IV clinical trial development.
  • Designs and analyzes clinical trials.
  • Maintains the statistical and analytical integrity of clinical trials analyzed. 
  • Participates in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, and interpreting statistical results for clinical study reports.
  • Acts as the lead statistician on clinical research projects and help with SAS programming.
  • Provides statistical expertise for study design of clinical trial protocols.
  • Writes statistical methods section of the study protocol.
  • Develops statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed.
  • Performs all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data. Performs validation of statistical results.
  • Provides input to key sections of clinical study reports and various regulatory documents.

 

Skills:

  • A minimum of 8 years experience in the Pharmaceutical, Medical Products industry, pharmaceutical product development or pharmaceutical formulations development is required.
  • Excellent analytical skills with the ability to process scientific and medical data is required.
  • Must be able to work independently and in teams.  
  • Must have a thorough knowledge of SAS software.  
  • Must have demonstrated problem solving abilities. 
  • Strong organizational skills are required.
  • Strong written and verbal communication skills are required.
  • Must have demonstrated good interpersonal skills.
  • Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).

 

Education:

  • A minimum of a Masters in a statistics discipline is required. 
  • A PhD degree in a statistics discipline is preferred. 
  • Equivalent experience may be accepted.
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