Director, Biostatistics - Directeur, Biostatistiques

The Director, Biostatistics will have the overall responsibility of the Biostatistics team comprised of Biostatisticians and Statistical Programmers.

The Director, Biostatistics will provide strategic leadership and oversight of resources, end-to-end Biostatistical deliverables. The Director, Biostatistics will also work within the Biostatistics department and cross-functionally to improve processes, harmonize strategies, activities, and tools, while ensuring company Standard Operating Procedures (SOPs), standards, processes, and trainings are in line with latest ICH Guidelines, requirements from Regulatory Authorities, and Industry best practices. 

This role will be perfect for you if:

• You are looking to contribute your expertise to the growth of a specialized CRO
• You are a hands-on leader
• You have a master’s degree or PhD in Statistics, Biostatistics, or a related field with some applied statistics training relevant to the clinical trials, plus at least 15 years of clinical trials experience in biotechnology, pharmaceutical or CRO industry, including at least 10 years acting as a Lead Biostatistician.
• You have a minimum of 10 years of management experience.
• You are based in the Montreal region.

RESPONSIBILITIES

Leadership and culture

• Adhere and promote company organizational values and related expected behaviors.
• Inspire, lead, and develop all functions within Biostatistics by contributing to formulate a clear vision for the future and attracting and retaining top talent.

Operationnal excellence

• Ensure operational excellence and efficiency by: Ensuring adequate training and mentoring of Biostatisticians and Statistical Programmers, analyzing Key Performance Indicators (KPIs) and quality metrics to assure achievement of quality and compliance, leading the development and/or optimization of (new) Biostatistics standards and processes with specific focus on efficiency and quality while maintaining or exceeding industry best practices.
• Leading the development of flexible resourcing strategies to meet the evolving demands of the company when required.
• Ensuring the company cost-models for Biostatistics are competitive and contributing to the development of reduced cost-models when required.

Interdepartmental collaboration

• Work closely with the Risk-Based Study Management (RBSM) and Data Management (DM) Leaders and teams to ensure adequate statistical support is offered to these functions when planning and conducting clinical trials.
• Liaise with other company function leaders to influence, shape, and drive unified strategies related to integrated clinical research data, rapid hypothesis generation, and other relevant enterprise efforts.
• Participate in cross-functional internal initiatives to increase collaboration between departments, efficiency of the company standards and processes, and clinical trials overall quality.
• Keep oneself abreast with latest ICH Guidelines, requirements from Regulatory Agencies, and Industry best practices, including recommended/expected statistical methodologies and electronic submission requirements.

Statistical expertise

• Assist influencing and providing good faith challenge to the broader clinical organization with respect to clinical development decisions and data interpretation.
• Evaluate and implement innovative study designs and novel statistical methodologies across each of the indications in dermatology, rheumatology, and other therapeutic areas.
• Serve as a Biostatistics Subject Matter Expert (SME) to the Biostatistics team members and clinical trial study teams.
• Liaise with clients regarding the conduct of statistical methodology, data analysis and interpretation, and regulatory issues.
• Provide statistical support for the strategic planning, authoring, and review of protocols (incl., sample size calculations or validation), manuscripts, and other scientific data disclosures, ensuring planned statistical design and analysis clearly and robustly address the objectives of clinical trials and programs of studies.
• Perform peer-review of Unblinding Plans, Statistical Analysis Plans (SAPs), and results from complex statistical analyses/models and provide input into statistical sections of clinical study reports (CSRs) to ensure results from statistical analyses are correctly performed, reported, and interpreted.
• Conduct statistical analysis for Investigator Initiated Studies (IISs) and internal R&D projects.
• Serve as a member of Protocol Review, Safety Review, and other governance committees, as designated.
• Serve as the company Biostatistics representative at regulatory meetings, inspections/audits, and on company partnership committees.

Management of training and SOP's

• Be responsible for the development/maintenance/review of (new) SOPs and trainings provided to Biostatisticians and/or Statistical Programmers, ensuring SOPs and trainings are in line with latest ICH Guidelines, requirements from Regulatory Authorities, Industry best practices, and the company SOPs, standards and processes.

Operational supervision

• Provide direct and indirect oversight of biostatistical operations by: 
• Planning the Biostatistics team annual budget.
• Acting as project manager for Biostatistics stand-alone work.
• Ensuring the scope of work and budget for Biostatistics activities are appropriate at initiation of clinical trials and overseeing change order estimation when needed.
• Overseeing resource allocation of Biostatisticians and Statistical Programmers on clinical trials and internal R&D projects and monitor timelines to ensure biostatistics deliverables are sent within agreed timelines.
• Being responsible for the general financial health of clinical trials by monitoring HPIs and KPIs, and supporting Lead Biostatisticians with revenue recognition, budget forecast, and invoices initiation.
• Ensuring all trainings assigned to oneself as well as to direct and indirect reports are completed on time.
• Providing direct reports with appropriate support and ensuring support provided to indirect reports is appropriate, adequate, and efficient
• Ensuring direct and indirect reports annual goals are appropriate and align with company organizational values as well as with Biometrics department annual goals.
• Conducting performance review of direct reports and contributing to performance review of indirect reports.
• Supporting Leads, Oversights, and (Line) Managers with de-escalation of potential escalations to prevent escalations and/or contributing to successful resolution of escalations when needed.
• Acting as the system owner of a computerized system (i.e., software/tool).Participating to the hiring process of new Biostatisticians and Statistical Programmers
• Overseeing biostatistics and/or statistical programming activities and deliverables performed by Biostatistician and/or Statistical Programmer contractors and/or external vendors to ensure outsourced activities/deliverables are conducted according to the industry and company standards.

IDEAL PROFILE

Education 

• Master’s degree or PhD in Statistics, Biostatistics, or a related field with some applied statistics training relevant to the clinical trials, plus at least 15 years of clinical trials experience in biotechnology, pharmaceutical or CRO industry, including at least 10 years acting as a Lead Biostatistician.

Experience 

• Minimum of 10 years of management experience required.
• Extensive knowledge of drug development process, ICH guidelines (including but not limited to, ICH E6, E9, and E9(R1)); relevant Health Canada (HC) and Food and Drug Administration (FDA), and European Medicines Agency (EMA) regulations, guidelines, and electronic data submission requirements (e.g., CDISC standards and guideline) required.
• Extensive exposure to clinical trial data, SAP, TLF Shells, and specifications required.
• Comprehensive knowledge of issues surrounding analysis and reporting of clinical trials data.
• Ability to make statistical concepts understandable to non-statisticians.
• Experience with regulatory interactions and submissions across multiple regions.
• Advanced working knowledge of SAS required.
• Ability to create and develop high-performing teams; coach and develop team members.
• Experience with resource allocation and budget planning required.
• Experience developing strategies in collaboration with other cross-functional leaders in complex organizational environments required.
• Prior experience shaping integrated strategies related to data collection, integration, and analysis with a goal to promote rapid hypothesis generation, testing, and decision making is highly desirable.
• Very organized and detail-oriented, with effective project planning and time management skills.

Knowledge and skills

• Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands.
• Must be able to work independently and as part of a team.
• Strong verbal and written communication skills in English; French an asset.