Director, Biostatistics

Director, Biostatistics - Directeur, Biostatistiques The Director of Biostatistics will provide strategic leadership and oversight of the Biostatistics team and end‑to‑end biostatistical deliverables. The role will work inter‑functionally to improve processes, harmonize strategies, and ensure company SOPs, standards, and training align with the latest ICH guidelines, regulatory requirements, and industry best practices. Qualifications Master’s degree or PhD in Statistics, Biostatistics, or a related field with applied statistics training relevant to clinical trials. Minimum 15 years of clinical trials experience in biotechnology, pharmaceutical, or CRO industry, including at least 10 years acting as a Lead Biostatistician. Minimum 10 years of management experience. Strong knowledge of drug development process, ICH guidelines (E6, E9, E9(R1)), and regulatory requirements from Health Canada, FDA, and EMA. Advanced working knowledge of SAS and expertise in CDISC standards. Experience with regulatory interactions and submissions across multiple regions. Strong verbal and written communication skills in English; French an asset. Based in the Montreal region. Responsibilities Adhere to and promote company values and expected behaviors. Inspire, lead, and develop the Biostatistics team, formulate a clear vision, attract and retain top talent. Ensure operational excellence: provide training and mentorship, analyze KPIs, develop and optimize biostatistics standards and processes with a focus on efficiency and quality. Develop flexible resourcing strategies and maintain competitive cost models for Biostatistics. Work closely with Risk‑Based Study Management and Data Management leaders to provide adequate statistical support during trial planning and execution. Liaise with other company function leaders to shape integrated clinical research data strategies. Serve as the company biostatistics representative at regulatory meetings, inspections/audits, and partnership committees. Plan the Biostatistics team’s annual budget and oversee resource allocation, budget forecasting, invoices, and financial health of clinical trials. Provide direct and indirect oversight of biostatistical operations, including project management of stand‑alone work, change order estimation, and monitoring timelines for biostatistics deliverables. Contribute to performance reviews of direct reports and support indirect reports with appropriate support. Benefits Flexible work schedule Permanent full‑time position Comprehensive benefits: medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities Ongoing learning and development opportunities About Indero Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since 2000, Indero has built a strong reputation for quality research and service excellence. Based in Montreal, Indero continues to grow in North America and Europe. Equal Opportunity & EEO Statement Indero is committed to providing equitable treatment and equal opportunity to all individuals. Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Canada. EEO All qualified applicants will be considered for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, sexual orientation, pronouns, protected veteran status, or protected disability status. #J-18808-Ljbffr