Principal Biostatistician

1 month ago

Chennai, India Pfizer Full time
ROLE SUMMARYDesign, 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.

ROLE RESPONSIBILITIESProvide 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.

Accountable for study level statistical deliverables on assigned projects.

Ensure that all study 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.

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.

This is an individual contributor role.BASIC QUALIFICATIONSAdvanced degree (Masters, PhD) in Statistics, Biostatistics, or related field.

5-8 yrs. of relevant experience for Masters level, entry level Ph.D. as long as the Ph.D. research work is in a relevant area

Experience in clinical trials is necessary for Masters degree, desirable for Ph.D.

Strong statistical skills with application to clinical trials.

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

PREFERRED QUALIFICATIONSWorking knowledge of SAS, R

ORGANIZATIONAL RELATIONSHIPSReports to the Head of Statistics, India

Works within GBDM functional lines (Statistics, DMM, SPA) and with functions in GPD

Works with statisticians and project teams in Early Clinical Development, Vaccines Clinical Development as required

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

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