Senior Manager Biostatistics

Pfizer

(Pearl River, New York)
Full Time Travel Required
Job Posting Details
About Pfizer
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products.
Summary
This position will provide statistical support for clinical Phase I-IV projects in Vaccine Research & 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, develop publications of results, contribute to the overall clinical development plan as well as provide statistical oversight for Functional Service Provider (FSP) statisticians. 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 appropriate statistical methods of enhanced quantitative drug development.
Responsibilities
* Provide scientifically rigorous statistical input into clinical development plans, protocol development, regulatory submissions and questions, interpretation of statistical results, study design, statistical analysis plans and scientific and other product support projects. * Be accountable for study level and submission level statistical deliverables on assigned projects, including timeliness and quality of deliverables according to project plans * Co-ordinate statistical support activities under appropriate business models, e.g., Alliance Partners/FSPs, including allocation of resources to provide services in line with company priorities, and monitoring progress towards timely completion of services. * Develop effective collaborations with others within clinical teams and partner lines (such as Development Operations, Safety Risk Management, Regulatory) * 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 * Identify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making. * 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,, learnings across divisions and locations, and activities for process improvements.
Ideal Candidate
* Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization including regulatory authorities * Advanced degree in statistics, biostatistics or a related field: M.S. or Ph.D. plus minimum of 4 years experience in applied statistics; at least 2 years experience of vaccine clinical trials required * Relevant clinical trial and business experience providing an understanding of the processes associated with clinical, regulatory and marketing operations: - Track record of applying advanced statistical skills to clinical trials and submissions - Experience of achieving results through outsourcing partners/CROs - 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 within cross-functional teams.
Compensation and Working Conditions

Working Conditions

Occasional trips to New York, NY, or Collegeville, PA, may be required.

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