An Individual Contributor role
Productivehands onprogramming, supporting deliverables in the study/project/portfolio/standards team, ofmedium – highcomplex statistical programming deliverablesto support assets and study teams
Performs tasks independentlywith mentorship or advise from Programming Leads within the organization
Acts as co-lead/lead on selected projects/initiatives/activitiesand alsostudy deliverables as needed.
Guide, mentor, monitor programmers within the team and collaborate with SDSL’s on timelines, resourcemanagement anddeliverables with quality.
Is capable of handling standards/study programming specific activities independently including collaboration acrossstakeholders at varioustimezones
Ensures adherence tohigh qualityprogramming standards in their daily work
Ensure the tasks are completed on time with quality and are compliant to the processat withneeded guidance.
Work collaboratively with study teams and stakeholders such as clinicians and statisticians on milestones and deliverables.
Active self-learning and delivering on solutions in the space of statistical programming and data standards
Contribute toSDSAinitiatives globally and locally.
Job Responsibilities
Accountable formultiple projects/ongoing work activities (timelines, work plans, deliverables) of moderate complexity within a Work Team
Accountable for their assigned work supporting the standards/study deliverablesand alsotoassistSDSL’s with the team assignments.
Review/Develop/ValidateReviewdatasets, TFL as per CDISCaligned Standardsor DataStandards for Study/Project/Portfolio. (Portfolio)
Contributestoupto80% of their time toprogramming deliverables assigned within the scope of the function in either SAS, R or Pythonand 20% toself learning,developmentand growth
Explore the existing code base and execute/perform runs asrequired, also develop/modifyas per the needs and specifications suggested to the standards team asappropriate –(Standards Programming)
Ensures appropriate documentation and QC across the lifespan of the study forall oftheirprogramming deliverablesacross Standards, Programming and Submissions.
UnderstandImplementstandard/study/project/portfolio requirementsand specification and work with global stakeholders in ensuring completion of project/study/deliverable goals and milestones
Knowledgeable in core safety standards as well as TA standards pertinent to their project and lead development of standards necessary for their study
Exhibits routine and occasionally complexproblem solvingskills, seeking direction whenappropriate
Regularly update leads on progress and time estimations to ensure smooth daily operations andaccurateplanning
Support in accomplishing department and organization mission by completing assigned tasks
Acts as mentor to junior team members
Advances job knowledge tonextlevel byparticipatingcontributing in/to opportunities both globally and locally.
Basic Qualifications:
Bachelor or Master (preferred) Degree in Statistics,Computer Sciences, Engineering,Pharmacy, biologicalsciences, IT, or relatedfield
At least5 - 6years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.
Understandingof clinical data and drug development process, CDISC standardsrequired
Statistical Programming and SAS hand-on experience
Clinical trialsexpertisewith an understanding of data operations required for the reporting of clinical
Good understanding of ICH and regulatory guidelines
Working knowledge of clinical data and relevant data standards
Is able towork with stakeholders acrosstimezonesunder tight timelines
Strong written and oral communication skills, and timeand projectmanagement skills
Strong competencies and interests for innovation and problem solving
Proven ability tooperatewith limited oversight
Knowledge of at least 1 Therapeutic Area
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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