Statistical Programming Lead (Standards) SSPG
Pfizer Canada Inc.
Chennai, India
18h ago
  • ROLE SUMMARY : A highly productive, independent programming lead ensuring excellence in the delivery of clinical and data management ad hoc listingsThis role will provide oversight and mentoring of hands on clinical programming teamThis 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 reportsEnsures understanding of CDISC IG requirements, NCI Control Terminology, and programming of analysis ready datasets, tables, listings, and figures for which they are responsibleResponsible for the line management of direct reports
  • ROLE RESPONSIBILITIES :

    Will deliver through combination of oversight of local development team support as well as through hands on programmingWorks with department leadership and project teams to establish strategy, timelines, and resourcing of clinical programming and analysis of SSPG deliverablesAccountable for the quality and timely delivery of enterprise, study and asset level deliverables of standard and ad hoc clinical listingsEnsures planning is in place for all programmed deliverables including consideration of special data types and downstream uses of dataExperience extracting data from EDC systems (i.

    e., OC / RDC, InForm, or Rave)Experience with JReview and SpotFire is requiredWorks with clinicians, statisticians, data managers, programming resources and other colleagues as appropriate to ensure clear specifications for programmed deliverables are in placeWill contribute to department level initiativesProactive at communicating potential issues to upper managementAnticipates 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 fieldAt least 9 years of hands-

    on clinical programming experience working with SAS, JReview and Spotfire within the pharmaceutical, biotech, CRO, or Regulatory AgencyClinical trials expertise with a thorough understanding of data operations required for the reporting of clinical trial dataGood understanding of ICH and Regulatory GuidelinesRoutine problem solving skills, developing the ability to solve complex problems using skills based on experience and extrapolation to new situationsThorough understanding of clinical data and relevant data standardsKnowledge of vendor processesDemonstrated experience in developing successful partnerships within study teamsStrong written and oral communication skills, and project management skillsAbility to present technical information to a non-

    technical audienceProven ability to operate independentlySome exposure working across international boundaries and culturesAbility to manage customer expectationsAbility to manage work of others in a remote and / or global settingCDISC 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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