Pfizer Canada, Inc
This position will provide statistical support for projects in the Inflammation and Immunology disease area in Pfizer Research and Development. The qualified candidate will collaborate and work closely with project / study teams and provide statistical expertise in designing clinical trials, developing protocols, writing statistical analysis plans, performing statistical analyses, interpreting and presenting results, writing/reviewing reports, and publishing manuscripts through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory queries. Successful candidate will make contributions through quantitative and creative thinking as well as proactively staying in the front of the current development of statistical methodologies.
- Provide scientifically rigorous statistical input into project development plans, regulatory submissions and questions, interpretation of statistical results, study design, statistical analysis plans and scientific and commercialization projects.
- Be accountable for study level and submission level statistical deliverables on assigned projects, including timeliness and quality of deliverables according to project plans.
- Develop effective collaborations with others within clinical teams, partner lines (such as, Development Operations, Pharmaceutical Sciences, Safety Risk Management, Regulatory), and external regulatory, industry, professional and academic organizations.
- Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
- Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, modeling and simulation in support of various activities, support for publications, scientific presentations, and support to product defense.
- Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, study managers, programmers – for assigned studies and regulatory submissions
- Provide input to the Statistics Group Lead to plan support for assigned studies and submissions.
- Communicate and collaborate with other project statisticians within the unit to ensure consistency of statistical approaches across studies and alignment with approaches used in phase III regulatory submissions.
- Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
- Participate in research on statistical methodology and its applications pertinent to the Pfizer business needs.
- Help maintain a strong statistics community at Pfizer through collaborations, scholarship, presentations and learnings across divisions and locations.
- Masters in Statistics/Biostatistics or related field with moderate experience in clinical trials, or PhD in Statistics/Biostatistics
- Effective verbal and written communication skills
- Understanding of broad statistical theory and its application
- Experience with R or SAS programming languages
- Effectively and clearly explaining statistical concepts to colleagues without statistical training
- Work collaboratively as a team member
- Strong computational skills
- Experience with different study designs, protocol development, and statistical analysis plan writing
- As a key member of project team, this position will interact directly with Clinical (Clinicians), Clinical Pharmacology, Statistical Programming, Data Management, Regulatory Strategy and Operations, Medical, Outcomes Research, Commercial, Operations and contract organizations supporting project deliverables.
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Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!Medical