Clinical Statistics Lead (Manager)
This position will provide statistical support for projects in the Immunology & Inflammation 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 quantitative drug development.
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
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 Head 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.
Ph.D. in Statistics (or related field). No professional experience required with a Ph.D.
Good publication experience.
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.
Relocation assistance is available for this position.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Medical#LI-PFE