An Individual Contributor role
Productivehands onprogramming, supporting deliverables in the study/project/portfolio/standards team, of medium – high complex statistical programming deliverables to support assets and study teams
Performs tasks with limited supervision early in role and independently later in role.
Is capable of handling standards/study programming specific activities independently including collaboration across stakeholders 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 process at Pfizer with needed 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 to SDSA initiatives globally and locally.
JobResponsibilities :
Accountable for their assigned work supporting the standards/study deliverables
Contributes toupto80% of their time to programming deliverables assigned within the scope of the function in either SAS, R or Python and 20% toself learning, development and growth.
Review/Develop/Validate datasets, TFL as per CDISC aligned Pfizer Standards or Pfizer Data Standards for Study/Project/Portfolio (TA or StudyProgramming)
Explore the existing code base and execute/perform runs as required, also develop/modify as per the needs and specifications suggested to the standards team as appropriate – (Standards Programming)
Ensures appropriate documentation and QC across the lifespan of the study forall oftheirprogramming deliverablesacross Standards, Programming and Submissions.
UnderstandDevelop/Reviewstandard/study/project/portfolio requirements, specifications to gain deeper understanding of expectations and programming requirements, by collaborating with stakeholders.
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 when appropriate.
Regularly update leads on progress and time estimations to ensure smooth daily operations and accurate planning
Advances job knowledge to next level by participating/contributing in/to opportunities both globally and locally.
Qualifications/ Skills:
Bachelor or Master (preferred) Degree in Statistics, Computer Sciences, Engineering, Pharmacy, biological sciences, IT, or related field.
3.5 -4 years relevant experience in SAS or R programming and working knowledge of clinical trials
Understanding of clinical data and drug development process, CDISC standardsrequired
Clinical trialsexpertisewith an understanding of data operations required for the reporting of clinicaltrial data.
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
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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