Clinical Statistician - Cambridge
💼 Graduate Job
AI generated summary
- The candidate must have a Master's or PhD in Statistics/Biostatistics, strong communication skills, broad understanding of statistical theory, experience with R or SAS programming, ability to explain concepts to non-statisticians, and collaborative teamwork skills. Preferred qualifications include strong computational skills, experience with study designs and protocol development, and writing statistical analysis plans.
- The Clinical Statistician in Cambridge will provide statistical input for projects, regulatory submissions, and interpretation of results. They will collaborate with clinical teams and external organizations, ensure compliance with regulations, deliver statistical analyses and reports, and contribute to research on statistical methodology.
- 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.
- Basic qualifications:
- 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
- Preferred qualifications:
- Strong computational skills
- Experience with different study designs, protocol development, and statistical analysis plan writing
Area of Responsibilities
- 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.