Senior Biostatistician

  • Contract
  • Remote

SimulStat

To Apply for this Job Click Here

12-month remote contract with potential to extend long-term

The Senior Biostatistician responsibilities including but not limited to:
 

  • Assist in strategic planning and develop optimal clinical development plans with cross-functional drug development teams.
  • Oversee multiple studies for one compound to ensure the consistency of statistical work standards.
  • Responsible for writing statistical methodology section of the protocol, including sample size calculation.
  • Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS or ISE.
  • Plan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activities.
  • Direct the activities of internal and external statistical programmers to ensure the intended analyses are performed, and analysis data sets and their specifications are in place following CDISC standards.
  • Review and comment on eCRFs, annotated eCRFs, edit checks documents and other clinical data management related documents.
  • Lead the cross functional team to develop IWRS and oversee system testing.
  • Participate in operations meetings and address issues related to biostatistics.
  • Support and participate in the preparation of study reports, regulatory submissions and annual IND safety update reports.
  • Perform ad hoc analyses and validation of analysis results.
  • Write simulation code and simulation report in compliance with regulatory agency requirements for adaptive design trials.

Qualifications
 

  • Ph.D. in statistics/biostatistics with minimum 8 years of biopharmaceutical statistics experience; Master’s degree in statistics or biostatistics with a minimum of 10 years of experience with specific experience in late stage drug development, including phase IIb, phase III, and submissions in the pharmaceutical industry.
  • Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
  • Experience in Biostatistics, SAS programming, and clinical data management in a regulated clinical research environment
  • Knowledge of missing data handling, multiple comparisons, and simulation techniques.
  • Experience in organizing regulatory submissions such as BLA, NDA, sNDA, and MAA submissions.
  • Good working knowledge of ICH, FDA and GCP regulations and guidelines
  • Experience in the neurology/cardiovascular therapeutic areas desirable

 

To Apply for this Job Click Here

  Apply with Google   Apply with Twitter
  Apply with Github   Apply with Linkedin   Apply with Indeed
  Stack Overflow