Principal Biostatistician (North & South America)

The Bioforum Biometrics department is growing, and we have an opportunity for an experienced biostatistician to join our group. This position is for candidates located in either North America (including Canada) or South America (remote).

Purpose: Works alongside the Director: Biostatistics to provide biostatistical support and services related to clinical trials. Act as Statistical Lead on clinical trials.

Required skills:

• 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

Duties will include:

• 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.