Senior Biostatistician at Bioforum the Data Masters

Required skills:

• Minimum 6 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 will be an advantage) in a statistics related field.

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.
• Generate randomization schemes.
• Review statistical output produced by the statistical programming team.
• Contribute to department wide initiatives to improve quality and efficiency.