Associate Director, Biostatistics

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. 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 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.
Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports.
Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
Develop effective collaborations with others within clinical teams and partner lines (such as Development Operations, Safety Risk Management, Regulatory).
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.
Qualifications

Candidate demonstrates a breadth of diverse leadership experiences and cap

abilities 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.

BASIC QUALIFICATIONS

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.
Knowledge and application of statistical modeling, simulation, meta-analysis and other complex modeling approaches using a variety of data sources is desirable.

PHYSICAL/MENTAL REQUIREMENTS

Ability to perform mathematical and statistical calculations.
Ability to perform complex data analysis.