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.
Skills Required
- Minimum 8 years' experience as a biostatistician working on clinical trials.
- Knowledge of advanced statistical methodology for clinical trial analysis.
- In-depth knowledge of industry guidelines (GCP, ICH E9, regulatory guidelines).
- Study/Project lead experience and customer interaction experience.
- Attention to detail.
- Excellent communication skills.
- Honours degree in a statistics related field.
- Master's degree or Ph.D in a statistics related field (advantage).
- Experience interacting with a regulatory agency (advantage).
- Development of SAS programs for study TLFs and advanced analyses.
- Experience with ADaM and/or derived dataset specifications.
- Statistical review and preparation of SAP, protocol statistics sections, and CSR statistical interpretation.
- Training and mentorship of junior statisticians.
What We Do
Bioforum is a biometric contract research organization that provides clinical data solutions for pharmaceutical, biotechnology, and medical-device sponsors. Its services include clinical data management, biostatistics, statistical programming, medical writing, data integration, and regulatory-ready reporting. Bioforum helps optimize clinical-trial design, data collection, analysis, and oversight, supporting sponsors throughout the development process and accelerating delivery of new therapies to patients.
