Director, Biostatistics – Montreal, Canada
Location: Montreal, Canada
Employment Type: Permanent, Full-time
Professional Level: Director
About the Role
Indero, a leading Contract Research Organization (CRO) specializing in dermatology and rheumatology, is seeking an experienced Director of Biostatistics to provide strategic leadership for its biostatistics team, including Biostatisticians and Statistical Programmers.
This senior leadership role oversees end-to-end biostatistical deliverables, drives operational excellence, harmonizes processes across teams, and ensures compliance with the latest ICH guidelines, regulatory requirements, and industry best practices. The Director will work cross-functionally to optimize study designs, statistical methodologies, and reporting standards for clinical trials in biotechnology, pharmaceutical, and CRO settings.
This position is ideal for hands-on leaders who want to shape the growth of a specialized CRO while providing mentorship, strategic direction, and operational oversight.
Key Responsibilities
Leadership and Culture
Lead, inspire, and develop the biostatistics team to deliver high-quality statistical outputs.
Promote organizational values, foster a culture of collaboration, innovation, and reliability.
Attract, retain, and mentor top biostatistical talent to build high-performing teams.
Operational Excellence
Oversee training, mentoring, and professional development of Biostatisticians and Statistical Programmers.
Monitor KPIs and quality metrics to ensure compliance and delivery excellence.
Optimize and standardize biostatistical processes and SOPs, enhancing efficiency and quality while maintaining industry-leading standards.
Manage flexible resourcing strategies and cost models to align with evolving company and project needs.
Cross-Functional Collaboration
Work closely with Risk-Based Study Management (RBSM) and Data Management (DM) teams to provide statistical guidance throughout clinical trials.
Partner with other functional leaders to develop unified strategies for clinical data integration, rapid hypothesis generation, and enterprise-level decision-making.
Participate in cross-functional initiatives to improve operational efficiency and clinical trial quality.
Statistical Expertise
Provide expert guidance on study design, statistical methodology, and data interpretation across multiple therapeutic areas, including dermatology and rheumatology.
Serve as Subject Matter Expert (SME) for the biostatistics team and clinical study teams.
Oversee development and peer-review of Statistical Analysis Plans (SAPs), TLF shells, and study results, ensuring accuracy, regulatory compliance, and clarity.
Support investigator-initiated studies (IIS) and internal R&D projects.
Represent the biostatistics function in regulatory interactions, audits, and partnership meetings.
SOP and Training Management
Develop, maintain, and review biostatistics SOPs and trainings in compliance with ICH guidelines and industry standards.
Ensure all team members complete mandatory training in a timely manner.
Operational Oversight and Budgeting
Plan and manage the biostatistics team budget, resource allocation, and project timelines.
Monitor KPIs and HPIs to ensure financial and operational health of clinical trials.
Oversee performance management, goal setting, and professional development of direct and indirect reports.
Supervise external contractors or vendors to ensure adherence to internal and industry standards.
Required Qualifications
Education
Master’s or PhD in Statistics, Biostatistics, or related field with applied statistics training relevant to clinical trials.
Experience
Minimum 15 years of clinical trial experience in biotechnology, pharmaceutical, or CRO environments.
At least 10 years as Lead Biostatistician and 10 years of management experience.
Extensive knowledge of drug development processes, ICH guidelines (E6, E9, E9(R1)), and regulatory requirements (FDA, Health Canada, EMA).
Advanced experience with clinical trial data, SAPs, TLF Shells, and statistical specifications.
Advanced SAS programming skills required.
Proven ability to build, coach, and lead high-performing biostatistics teams.
Experience in budget planning, resource allocation, and cross-functional collaboration in complex organizational environments.
Knowledge of integrated strategies for data collection, analysis, and rapid hypothesis generation is highly desirable.
Skills and Competencies
Strong analytical and strategic thinking skills with ability to influence clinical and operational decisions.
Ability to translate complex statistical concepts for non-statisticians.
Excellent communication skills in English; French is an asset.
Exceptional organizational, project management, and time management capabilities.
Ability to work independently and collaboratively in a high-paced environment.
Work Environment and Benefits
Permanent, full-time position based in Montreal, Canada.
Flexible working schedule and a supportive, innovation-driven work culture.
Comprehensive benefits package, including medical, dental, vision, retirement plan, personal days, and wellness programs.
Ongoing professional development and learning opportunities.
About Indero
Indero is a global CRO with a strong reputation in dermatology and rheumatology clinical research, delivering exceptional services to biotech and pharmaceutical clients since 2000. With operations across North America and Europe, Indero combines scientific rigor, innovative solutions, and patient-centric approaches to deliver high-quality clinical trials at scale.
Indero is committed to equity, diversity, and inclusion, providing accommodations throughout the recruitment process for candidates with disabilities. Only candidates legally authorized to work in Canada will be considered.
Apply Now
Advance your career as Director of Biostatistics at Indero, where you will lead innovative clinical research, mentor top talent, and influence data-driven decisions across global clinical trials.
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