Pfizer Hiring for Senior Statistical Programming Lead at Chennai, Tamil Nadu, India Full Time

Job Description

Role Summary:

This role is the programming point of contact at the asset, indication, or study level. Could have responsibility for multiple indications or studies depending on size

Ensures 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.

In addition to management of the deliverables, the senior lead will also provide consultation to the asset/submission teams with respect to planning of programmed asset deliverables as well as standards strategy

Ensures adherence to high quality programming standards in the production of clinical reports and submission documentation

Will have people management responsibilities

Will be a mentor to more junior colleagues

Works with department leadership and project teams to establish strategy, timelines, and resourcing of statistical programming and analysis deliverables within their area.

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 management of internal resource or oversight of external resources.

Ensures appropriate documentation across the lifespan of the study and asset for all programming deliverables and verifies proper Trial Master File filings when appropriate.

Ensures planning is in place for all programmed deliverables including consideration of special data types and downstream uses of data

Works with statisticians, programming resources, and other colleagues as appropriate to ensure clear specifications for programmed deliverables are in place.

Will be knowledgeable in core safety standards as well as Therapeutic Area standards pertinent to their project, may serve on a data standards board, and most likely will be leading implementation and potentially development of standards in their project area.

Responsible for managing issues at the study level as they arise and proactively communicating larger asset or general programming issues to management while serving to provide solutions.

Provides solutions to complex programming issues using problem solving skills and previous experience.

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

Qualifications & Skills:

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

Atleast 12 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency

Atleast 3 years of People Management experience

Statistical Programming and SAS hands-on experience

Clinical trials expertise with a thorough understanding of data operations required for the reporting of clinical trial data.

Good understanding of ICH and Regulatory Guidelines

CDISC experience highly desirable

Routine problem solving skills, developing the ability to solve complex problems using skills based on experience and extrapolation to new situations.

Thorough understanding of clinical data and relevant data standards

Extensive knowledge of routine statistical methodology and its application to programming

Knowledge of vendor processes

Demonstrated experience in developing successful partnerships within study teams

Strong written and oral communication skills, and project management skills

Ability to present technical information to a non-technical audience

Proven ability to operate independently.

Some exposure working across international boundaries and cultures.

Ability to manage customer expectations.

Ability to manage work of others in a remote and/or global setting

Work Location Assignment: Flexible

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

Medical

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