BioForum

The Association of Biotechnological Companies BioForum

Principal Biostatistician

Clinical ResearchClinical ResearchFull TimeRemoteTeam 1-10Since 2021Company SiteLinkedIn

Location

United States

Posted

107 days ago

Salary

Not specified

Bachelor Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

• Works alongside the Director: Biostatistics to provide biostatistical support and services related to clinical trials. • Act as Statistical Lead on clinical trials. • Ownership of the statistical aspects and requirements on clinical trials done by Bioforum. • Provide guidance on study designs and statistical methodology as appropriate. • Interact with the customer and provide guidance / input on the statistical requirements and queries in the planning and during the conduct of the trial. • Statistical review and preparation of documentation, including the statistics section of the study protocol, Statistical Analysis Plan, and statistical sections / results interpretation of Clinical Study Reports (CSRs). • Provide training/mentorship to junior statisticians. • Review Table, Listing and Figure (TLF) shells associated with the study SAP. • Review ADaM and/or derived dataset specifications as required. • Development of SAS programs for study TLFs focussing on efficacy and/or advanced statistical methodology. • Review statistical output produced by the statistical programming team. • Contribute to department wide initiatives to improve quality and efficiency.

Job Requirements

  • Minimum 8 years’ experience as a biostatistician working on clinical trials.
  • Knowledge of advanced statistical methodology used in the analysis of clinical trial data
  • In-depth knowledge of industry guidelines (GCP, ICH E9, regulatory guidelines)
  • Study / Project lead / Customer interaction experience
  • Attention to detail.
  • Excellent communication skills.
  • An Honours degree (a Masters degree / Ph.D will be an advantage) in a statistics related field.
  • Experience interacting with a regulatory agency will be an advantage

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