Manager, Statistics

Pfizer; United Kingdom; Remote; GBP 70,000 - 100,000; Full time

Job summary

Pfizer is seeking a senior statistician to design, analyze, and interpret clinical trials and observational studies in line with regulatory requirements and Pfizer standards. You will provide rigorous statistical leadership for development programs and regulatory submissions.

Responsibilities include planning analyses, communicating results, and mentoring statisticians while ensuring timely, high-quality deliverables and cross-functional collaboration across clinical, regulatory, and HTA teams.

Qualifications

• Advanced degree in statistics/biostatistics or related field.
• Experience with clinical trials and real-world data.
• Ability to lead cross-functional teams and communicate statistical concepts clearly.

Responsibilities

• Provide scientifically rigorous statistical expertise on study design, analysis plans, interpretation, and reporting.
• Plan, deliver, and communicate statistical analyses and reports, including regulatory and HTA submissions.
• Accountable for study- and submission-level statistical deliverables.
• Ensure quality, productivity, and adherence to best practices in statistics.
• Develop internal and external collaborations with clinical, regulatory, payer, and academic partners.

Skills

Statistical leadership

Strong communication

Cross-functional collaboration

Education

Advanced degree in statistics/biostatistics

Job description

JOB SUMMARY Design, analyze, and interpret clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer standards, and best practices. Provide scientifically rigorous statistical expertise on: o Projects and protocols in support of clinical development and for publication, presentation, access negotiation, and other evidence generation efforts for Pfizer products; o Regulatory and Health Technology Assessment (HTA) submissions; and o Projects to maximize the value of aggregate clinical and real world data in support of drug development and other scientific strategies. Provide study and other project level statistical counsel and communicate resource needs to teams.JOB RESPONSIBILITIES Provide scientifically rigorous statistical expertise on study design, statistical analysis plans, interpretation and communication of statistical results, project development plans, regulatory issues, and scientific and other product support projects. Provide planning, delivery, and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, support for publication activities, scientific presentations, and support to product defense. Accountable for study or project level and submission level statistical deliverables on assigned projects. Accountable for implementation of quality, productivity, and other best practices. Develop effective collaborations internally and externally including, but not limited to, clinical teams, partner lines, regulatory, payer, industry, professional and academic organizations. Ensure all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards. Maintain compliance with all required training. Provide statistical input and leadership to cross-functional activities, in collaboration with other statisticians, study managers, and programming colleagues, for assigned studies or regulatory and HTA submissions. Provide to Statistics Group Lead and/or Head, Statistics input for planning support for assigned projects, studies, and submissions. Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects. Comply with all statistics and quality processes, Pfizer data standards that are applicable to statistical outputs, and support processes that require statistical input. Communicate and collaborate with other project statisticians within R&D, or other organizations where applicable, to ensure consistency of statistical approaches across studies and alignment with approaches used in regulatory submissions. Present 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.QUALIFICATIONS / SKILLS Advanced degree in statistics, biostatistics, or related field. Relevant clinical trial, real-world data, and business experience providing an understanding of the processes associated with clinical, regulatory, and marketing operations. Capability to provide statistical leadership to cross -functional teams at the protocol or project level. Strong statistical skills with application to clinical trials and/or analysis of observational studies. Effective verbal and written communication skills.ORGANIZATIONAL RELATIONSHIPS Reports to Statistics Group Lead or Head, StatisticsRESOURCES MANAGED Varies with career ladder level and project need--Statistics Leads may supervise the work of other statisticians. No direct budgetary responsibilities.The closing deadline for applications is September 24th.All applicants must have the relevant authorisation to live and work in the UK.