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Statistical Programming Group Lead (Director)

Pfizer


Location:
Chennai, TN 600006
Date:
11/22/2017
2017-11-222017-12-23
Pfizer
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Job Details

Summary







+ Support SPA India head to lead and manage an organization of 80+ in the India Statistical Programming Analysis department



+ Have direct management responsibilities, with expectation to train and mentor Statistical Programming Leads and Programmers under his/her purview. Hence this position will have two layers below (Statistical Programming Leads and Programmers)



+ Review annual individual objectives and development plans and perform periodic performance evaluation of direct reports following global or local corporate policy



+ In conjunction with the relevant TA lead, this role will have accountability for all the programming deliverables under his/her purview



+ Ensure excellence in the delivery of analysis ready datasets, tables, listings, and figures to advance research, development, and commercialization of the Pfizer portfolio following Pfizer SOPs and processes at the asset level



+ Ensure adherence to high quality programming standards in the production of clinical reports and submission documentation at the asset level







Responsibilities







+ Work with department leadership to help establish strategy for the programming discipline, especially in the context of the new India group



+ Work with asset teams to establish strategy, timelines, and resourcing of statistical programming and analysis deliverables within their area.



+ Be accountable for the quality and timely delivery of datasets and displays required for clinical study reports, submissions, product defense and commercial support based on analysis plans through leadership, and guidance of internal and external resources.



+ Be responsible for planning all programmed deliverables including consideration of special data types and downstream uses of data as well as contributing to the asset level/submission strategy.



+ Work with other asset level leads across statistics, clinical, regulatory and other functions as appropriate to ensure clear specifications for programmed deliverables are in place.



+ Be an expert in core safety standards as well as relevant Therapeutic Area standards, and demonstrate expertise in planning implementation and development of standards



+ Will contribute to, and lead department level initiatives. Will also contribute to broader initiatives outside of the department.







Qualifications







+ Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.



+ At least 10 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.



+ Statistical Programming and SAS hands-on experience



+ Clinical trials expertise with a thorough understanding of the drug development process and data operations required for the reporting of clinical trial data (e.g. study reports, regulatory submissions, safety updates, etc.)



+ Adept at solving problems using skills based on experience and extrapolation to new situations.



+ Expert knowledge of clinical data, regulatory requirements, and relevant data standards



+ Knowledge of vendor processes and best practices in outsourcing and oversight



+ Experience in leading a programming team for necessary deliverables at the asset level within a matrixed organization



+ Demonstrated experience managing complex projects and developing successful partnerships within study and asset teams



+ Strong written and oral communication skills, leadership, decision making, influencing, negotiation, and project management skills



+ Proven ability to operate independently in ambiguous situations



+ Sound knowledge and experience working across international boundaries and cultures.



+ Ability to manage customer expectations, anticipate potential objections, and influence others



+ CDISC experience highly desirable.







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