Pfizer Statistical Programming Lead (Standards) in Chennai, India

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 RESPONSIBILTIES

  • 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 skills based on experience and extrapolation to new situations

QUALIFICATIONS

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

  • At least 5 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.