Principal Biostatistician

ROLE SUMMARY:
Design, analyse, 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 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.
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 QUALIFICATIONS
Advanced degree (Masters, PhD) in Statistics, Biostatistics, or related field.
5-8 yrs. of relevant experience for master's 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 Master's degree, desirable for Ph.D.
Strong statistical skills with application to clinical trials.
Effective verbal and written English.
PREFERRED QUALIFICATIONS
Working knowledge of SAS, R
ORGANIZATIONAL RELATIONSHIPS
Reports 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
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical