QUALIFICATIONS / SKILLS

Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.
At least (8-15) 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 data operations required for the reporting of clinical trial data.
Good understanding of ICH and Regulatory Guidelines
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

CDISC experience highly desirable

Responsibilities:

Individual Contributor/Project or Application Manager/People Manager of small teams

A highly productive, independent programming lead ensuring 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

The programming point of contact at the study level, and will support at the asset/submission level(TA and Study) , supporting end to end deliverables in the study/project/portfolio/standards teamhigh complex statistical programming deliverables to support assets and study teams

Leading architecture development in Standards for major phases of delivery

Manage projects(mid and small sized) and/or manage small sized teams

Acts as co-lead/lead on selected projects/initiatives/activities and also study deliverables as needed.

Guide, mentor, monitor programmers within the team and collaborate with Senior SDSL’s on timelines, resource management and deliverables with quality.

Is capable of handling standards/study programming specific activities independently including collaboration across stakeholders at various timezones

Ensures adherence to high quality programming standards in their daily work

Ensure the tasks are completed on time with quality and are compliant to the process at Pfizer with needed guidance.

Work collaboratively with study teams and stakeholders such as clinicians and statisticians on milestones and deliverables.

Active self-learning and delivering on solutions in the space of statistical programming and data standards

Contribute to SDSA initiatives globally and locally.

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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1G5 Pfizer Healthcare India Private Limited

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