Manager, Statistics

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 Final date to receive applications is September 24th.

All applicants must have the relevant authorisation to live and work in the UK.