1+ months

Statistical Programming Lead (Standards)

Chennai, TN 600086
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Role Summary:

+ A highly productive, independent programming lead ensuring excellence in the delivery of enterprise, standard statistical programming encompassing the following areas: CDISC SDTM, ADaM, and TLF generation

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

+ Demonstrate experience working as part of a software development team and fundamental SDLC processes

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

+ Ensures adherence to Pinnacle 21 CDISC validation checks and high quality programming standards in their daily work

+ This role is the programming point of contact within the global standards development team

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

Role Responsibilities:

+ 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 statistical programming and analysis deliverables of our standards

+ Accountable for the quality and timely delivery of enterprise, study and asset level deliverables of standard statistical programming encompassing the following areas: CDISC SDTM, ADaM, and TLF generation

+ 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 of software development practices as defined within Pfizer's CDISC development framework

+ 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


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

+ At least 9 years relevant CDISC statistical/clinical programming 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 require

+ Pfizer CDARS experience desirable

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-01-15 Expires: 2019-03-17

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Statistical Programming Lead (Standards)

Chennai, TN 600086

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