This Job Vacancy has Expired!

Associate Director Biostatistics

Posted on Apr 5, 2021 by Pfizer

Pearl River, NY 10965
Research
Immediate Start
Annual Salary
Full-Time


ROLE SUMMARY


This position will provide statistical support for clinical Phase I-IV projects in Vaccine Research and 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 overall clinical development plan as well as provide statistical oversight for Functional Service Provider (FSP) statisticians. The successful candidate would also participate in regulatory submissions and developing responses 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 to facilitate product development.


ROLE RESPONSIBILITIES


Provide scientifically rigorous statistical input into clinical development plans, protocol development, statistical analysis plans, regulatory submissions and questions, interpretation of statistical analysis results, and other product support initiatives.
Be accountable for study and program 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, eg, 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.
BASIC QUALIFICATIONS


Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.


M.S. degree in statistics, biostatistics or a related field with minimum of 8-year experience in applied statistics; Or Ph.D. degree in statistics, biostatistics or a related field with minimum of 4-year experience.
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization including regulatory authorities.
Capability to provide statistical leadership within cross-functional teams.
PREFERRED QUALIFICATIONS


Ph. D. degree in statistics or biostatistics.
Relevant experience in the design, implementation, analysis and reporting of clinical trials, especially for vaccine development programs, 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 modeling, simulation, meta-analysis and other complex modeling approaches using a variety of data sources is desirable




Reference: 1152695767

Set up alerts to get notified of new vacancies.

Similar Jobs

Associate Director, Biostatistics

Palo Alto, CA

Annual Salary

Associate Director, Biostatistics

San Mateo, CA

Annual Salary

Associate Director, Biostatistics

San Diego, CA

Annual Salary

Associate Director, Biostatistics

Philadelphia, PA

Annual Salary

Associate Director, Biostatistics

Morris Plains, NJ

Annual Salary

Associate Director, Biostatistics

Myrtle Point, OR

Annual Salary

Associate Director, Biostatistics

Pearl River, NY

Annual Salary

Associate Director Biostatistics

Pearl River, NY

Annual Salary

Associate Director Biostatistics

San Francisco, CA

Annual Salary

Associate Director, Biostatistics

Cambridge, MA

Annual Salary