1+ months

Manager, Biostatistics

Pfizer
Chennai
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**ROLE SUMMARY**



+ Design, analyze, and interpret clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer standards, and best practices.

+ Provide statistical expertise and contributions for projects and protocols in support of clinical development.

+ Provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables.

+ Provide statistical expertise in maximizing the value of aggregate clinical data in support of scientific and drug development strategies.



**ROLE RESPONSIBILITIES**



+ Provide statistical input to study designs, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization projects

+ Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, support for publication activities, scientific presentations, and support to product defense.

+ Accountable for study level and submission level statistical deliverables on assigned projects.

+ Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.

+ Provide statistical input to cross-functional activities - collaborate with other statisticians, study managers, and other colleagues - for assigned studies and regulatory submissions

+ Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects.

+ Comply with all statistics and quality processes and standards that are applicable to statistical outputs, and support processes that require statistical input.

+ Communicate and collaborate with other project statisticians within the therapeutic area to ensure consistency of statistical approaches

+ Participate in technical forums on statistical methodology and its applications pertinent to business needs.

+ Help maintain a strong statistics community at Pfizer through collaborations, scholarship, presentations, and learnings across divisions.



**BASIC QUALIFICATIONS**



+ Advanced degree in statistics, biostatistics, or related field.

+ Capability to provide statistical leadership to cross -functional teams at the protocol level.

+ Strong statistical skills with application to clinical trials and/or analysis of observational studies

+ Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.



**PREFERRED QUALIFICATIONS**

At least 4 years of relevant clinical trial and business experience



\#LI-PFE



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Medical
Posted: 2019-11-27 Expires: 2020-03-28

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Manager, Biostatistics

Pfizer
Chennai

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