Hands on programming role, supporting deliverables in the study/project/portfolio/standards team, of medium or high complex statistical programming deliverablesMentored/Guided by Statistical Programming Leads within Standards/Study/Project/Portfolio/TA'sGuide, mentor, monitor programmers within the team and collaborate with SPL's on timelines, resource management and deliverables with quality.Ensures adherence to programming standards in their daily workEnsure 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 standardsContribute to SPA initiatives globally and locally.
Responsibilities:
Accountable for multiple projects/ongoing work activities (timelines, work plans, deliverables) of moderate complexity within a Work TeamAccountable for their assigned work supporting the standards/study deliverables and also to assist SPL's with the team assignments.Develop/Validate/Review datasets, TFL as per CDISC aligned Pfizer Standards or Pfizer Data Standards for Study/Project/Portfolio. (Portfolio)Explore the existing code base and execute/perform runs as required, also develop/modify/review as per the needs and specifications suggested to the standards team as appropriate - (Standards)Understand/Implement standard/study/project/portfolio requirements and specification and work with global stakeholders in ensuring completion of project/study/deliverable goals and milestonesEnsures appropriate documentation are completed for their deliverables and the deliverables within the team.Regularly update leads on progress and time estimations to ensure smooth daily operations and accurate planningAdvances job knowledge to next level by participating/contributing in/to opportunities both globally and locally.Support in accomplishing department and organization mission by completing assigned tasksActs as mentor to junior team members
Qualifications:
Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.At least 6-8 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.Statistical Programming and SAS hand-on experienceClinical trials expertise with an understanding of data operations required for the reporting of clinicaltrial data.Good understanding of ICH and regulatory guidelinesWorking knowledge of clinical data and relevant data standardsAbility to Identify and solve complex problemsExposure working across boundaries, with various stake holders.Strong written and oral communication skills, and project management skillsProven ability to operate with limited oversightKnowledge of at least 1 Therapeutic AreaProven ability to manage delivery under tight timelines.CDISC and submission experience desirable.
Location: Chennai or Mumbai
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