Associate Director – Biostatistics

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee clinical trial programs and projects for one or multiple clients, collaborating with senior leadership in Biostatistics, Statistical Operations, or Biometrics.

• Provide daily technical and operational guidance to project teams.

• Mentor, coach, develop, review, and advise both direct and indirect Biostatisticians and Statistical Programmers.

• Direct statistical and programming teams, while planning and executing project plans in partnership with clients and internal project leaders.

• Ensure robust statistical methodologies are applied across study design, sample size estimation, analysis planning, data handling, modeling, testing, analysis, and reporting.

• Offer statistical insights for protocol design and development, and take part in writing protocols and research proposals.

• Strategically contribute to drug development and commercialization at both study and therapeutic-area levels.

• Evaluate clinical data management deliverables.

• Draft and peer review Statistical Analysis Plans (SAPs), Statistical Reports, and the statistical methodology sections of Clinical Study Reports (CSRs).

• Conduct hands-on statistical analysis and modeling.

• Validate statistical tables, listings, and figures while performing comprehensive quality control of statistical deliverables.

• Review ADaM dataset specifications and perform quality control on ADaM datasets.

• Provide statistical consultation for the publication of trial results, and contribute to writing abstracts, manuscripts, posters, and presentations.

• Offer guidance to less experienced Biostatisticians.

• Ensure adherence to regulatory requirements and standards.

• Engage with regulatory agencies and assist Sponsors with new drug applications.

• Manage resources, conduct capacity analyses, benchmarking, and performance metrics.

• Maintain governing documents and contribute to ongoing improvements.

• Participate in the recruitment and evaluation of professional applicants.

• Support business development efforts, including cost estimates, proposals, bid defense meetings, and trade shows.

• Assist in project budget planning, tracking, reporting, out-of-scope tracking, cost estimates, and change orders.

⛳️ Requirements

• A Ph.D. in statistical science, mathematical analysis, or related fields with a minimum of 10 years of relevant experience, OR a Master’s degree in these areas with at least 13 years of relevant experience.

• Proven exceptional ability and performance.

• Expertise in statistical methodologies and regulatory requirements.

• Experience in clinical trial programs and projects, statistical analysis, modeling, programming, and reporting.

• Familiarity with clinical data management deliverables, such as eCRFs, data validation specifications, Data Review Plans, and Data Management Plans.

• Experience in writing Statistical Analysis Plans, Statistical Reports, Clinical Study Reports, abstracts, manuscripts, posters, and presentations.

• Knowledge of ADaM dataset specifications and quality control activities.

• Understanding of relevant regulatory requirements and applicable standards/conventions, including CDISC.

• Ability to interact with regulatory agencies and support new drug applications.

• Proficiency in statistical and programming resource management, capacity analysis, benchmarking, and performance metrics.

• Capability to engage in business development activities, including project budgeting, cost estimation, proposals, bid defense meetings, and change orders.

🏝️ Benefits

• Medical coverage.

• Dental coverage.

• Vision coverage.

• Life & AD&D insurance.

• Short- and long-term disability.

• Tuition reimbursement.

• Fitness reimbursement.

• Employee assistance program (EAP).

• Pension plan.

• Generous paid time off and sick leave.

• Opportunity to earn a performance-based bonus.

• Remote work from a home-based office anywhere in Canada in accordance with the Work from Home policy.