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Statistical Programming Lead (Standards)

Pfizer


Location:
Chennai, TN 600006
Date:
11/22/2017
2017-11-222017-12-23
Pfizer
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Job Details

**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.
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