Director, Biostatistics

ROLE SUMMARYThis position will provide statistical support for projects in the Rare Disease Category in Global Product Development. The successful candidate will collaborate with study teams working effectively to design studies, develop protocols, write statistical analysis plans, perform statistical analysis, write reports, present results summarizing findings, and develop publications of results.  Successful candidate would also participate in regulatory submissions and response to regulatory queries.  The candidate will directly contribute to Company success by increasing the strength of study designs, interpretability of results, regulatory strategy &  interactions, biomarker strategies and by implementing methods of enhanced quantitative drug development (EQDD).ROLE 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 submissionsProvide 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.QUALIFICATIONS Advanced degree in statistics, biostatistics, or related field.  M.S. in Statistics (or related field) plus significant proven experience in applied statistics; or Ph.D. in Statistics (or related field) with proven experience in applied statistics.Relevant clinical trial and business experience providing an understanding of the processes associated with clinical, regulatory and marketing operations.Strong statistical skills as applied to clinical trials and submissions. Knowledge and application of statistical modelling, simulation, meta-analysis and other complex modeling approaches using a variety of data sources is desirable.Capability to provide statistical leadership to cross-functional teams.Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization including regulatory authorities.ORGANIZATIONAL RELATIONSHIPSAs a key member of project team, 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.Work Location Assignment: FlexibleAll applicants must have the relevant authorisation to live and work in the UK.Purpose Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.  Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.Flexibility  We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!  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.DisAbility ConfidentWe 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#LI-PFESummaryLocation: United Kingdom - CambridgeType: Full time