Head of Biostatistics

Pulse Infoframe is a global health technology company focused on cancer and rare/orphan diseases. We believe that medical advances are made when data is shared across boundaries, and we are leaders in real-world data and the derived evidence and insights. Our customers include leading global pharmaceutical and biotechnology companies, academic medical centers, and patient advocacy organizations. The Pulse culture is fueled by a dedicated team of research scientists, data engineers, and product managers committed to making a difference. 

Position Summary 

The Head of Biostatistics role is responsible for overseeing all biostatistical activities and providing strategic leadership to the biostatistical analysts, and extensive support to the clinical epidemiology and platform technology teams at Pulse. The position plays a key role in the planning, execution, and analysis of clinical registries and research studies with strong project/product management and people skills to ensure the integrity and effectiveness of both data-driven and hypothesis-driven decision-making. This position ensures that protocols, methods, and analyses meet regulatory requirements, pharma specifications and industry standards globally. Initiative, fortitude, and proper decision-making to independently lead staff as a team-first player. 

Responsibilities 

1. Strategic Guidance.

Leadership of all biostatistics endeavors and data analysts, and extensive collaboration with the clinical epidemiology, software development and application configuration teams. Develop and implement real-world studies and registries aligned with company goals. Lead program evaluation for collecting, analyzing, and using 

information to assess the effectiveness and efficiency of programs, policies, and products. Collaborate with cross functional teams to lead and be accountable for all protocol and development, along with established and enforced statistical standards, policies, and procedures to ensure data quality, reliability, and ethical use. 

2. Registry/Study Design, Development, Implementation, and Management.

Lead all protocol and outcomes derivation from beginning to end. Lead the design of clinical registries and studies to ensure design, operation, statistical and epidemiological rigorous approaches, and methodologies. Develop plans, including statistical analysis plans (SAPs), and ensure they are followed throughout the study. Manage the overall product/project. 

3. Data Analysis and Interpretation.

Oversee and conduct statistical analyses of research studies. Interpret and communicate the results of analyses to support decision-making. Benchmarking and interpretation of data. Thorough understanding of how data is collected, stored, accessed, and analyzed to help advise on effective data management systems and infrastructure. Ensure data integrity and quality control procedures are followed. Communicate statistical findings and implications to non-statistical stakeholders effectively. 

4. Collaboration and Communication.

Collaborate with cross-functional teams across all levels of the organization, including IT development and engineering, regulatory affairs, commercial, legal, etc. Reporting, communicating, and presenting registry/study objectives, operations, statistical findings and similar insights to executives and other internal/external stakeholders in a clear, succinct, and actionable manner via meeting presentations, visuals, abstracts, posters, and manuscripts.  

5. Risk Management and Regulatory Compliance.

Identify and address clinical, epidemiological, and statistical risks company-wide, in registry products and study projects. Develop risk mitigation strategies. Collaborate with regulatory affairs teams to ensure that all research development and deliveries comply with regulatory requirements (e.g., FDA and EMA). Prepare and review data and analysis sections of regulatory submissions.  

6. Methodology.

Stay up-to-date with advancements in all regulatory, statistical, and clinical research methodologies and incorporate best practices and standards in registry and study protocol designs, adherence, and operations.  

Qualifications  

• Ph.D. in Biostatistics or a related field preferred.
• 15+ years of relevant experience in biostatistics, clinical epidemiology, and end-to-end study/registry operations and product management.
• Strong leadership and management capabilities. Effective communication and interpersonal skills.
• Must be exceptionally proficient in engaging with pharmaceutical clients to promote and deliver diverse aspects of the clinical analytics business. Demonstrates exceptional communication skills, deep domain knowledge, and the ability to convey intricate information in a clear and captivating manner throughout the entire process, starting from the initial proposal and defense, all the way through to production and ongoing support.
• Ability to translate complex statistical concepts into understandable language for non-experts.
• Extensive experience in clinical research and biostatistics within the biotechnology or pharmaceutical industry.
• Knowledge of regulatory guidelines (e.g., ICH, FDA) related to clinical trial and RWD design and analysis.
• Proficiency in statistical software (e.g., R), version control, database (e.g., SQL), and data visualization tools.
• Ability to work in a fast-paced, dynamic environment.
• Experience preferred in Oncology and rare diseases (lysosomal diseases, hepatology, and rare oncology).
• Ability to cross time zones in US, Canada, UK, Europe, and Australia.

Location 

Based in Canada with preference to London Ontario area.  

Reports to CEO and CDO  

Pulse Infoframe values diversity. We’re proud to be an equal opportunity employer and welcomes applicants from diverse backgrounds. If a job applicant requires an accommodation during the application or selection process, we will work with the applicant to meet the accommodation needs. 


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