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Clinical Programming Lead (Standards)


Chennai, TN 600006
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Job Details


+ A highly productive, independent programming lead ensuring excellence in the delivery of clinical and data management ad hoc listings

+ This role will provide oversight and mentoring of hands on clinical programming team

+ This role is the programming point of contact within the global lead of the Study Specific Programming Group (SSPG)

+ Ensures adherence to high quality programming standards in the production of clinical reports

+ Ensures understanding of CDISC IG requirements, NCI Control Terminology, and programming of analysis ready datasets, tables, listings, and figures for which they are responsible

+ Responsible for the line management of direct reports


+ Will deliver through combination of oversight of local development team support as well as through hands on programming

+ Works with department leadership and project teams to establish strategy, timelines, and resourcing of clinical programming and analysis of SSPG deliverables

+ Accountable for the quality and timely delivery of enterprise, study and asset level deliverables of standard and ad hoc clinical listings

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

+ Experience extracting data from EDC systems (i.e., OC/RDC, InForm, or Rave)

+ Experience with JReview and SpotFire is required

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

+ Will contribute to department level initiatives

+ Proactive at communicating potential issues to upper management

+ Anticipates and solves routine problems, while developing the ability to solve complex problems using skills based on experience and extrapolation to new situations


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

+ At least 5 years of hands-on clinical programming experience working with SAS, JReview and Spotfire within the pharmaceutical, biotech, CRO, or Regulatory Agency

+ 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

+ 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 require

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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