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  • An Individual Contributor role 
  • Productive hands on programming, supporting deliverables in the study/project/portfolio/standards team, of medium – high complex statistical programming deliverables to support assets and study teams 
  • Performs tasks independently with mentorship or advise from Programming Leads within the organization 
  • Acts as co-lead/lead on selected projects/initiatives/activities and also study deliverables as needed. 
  • Guide, mentor, monitor programmers within the team and collaborate with SDSL’s on timelines, resource management and deliverables with quality. 
  • Is capable of handling standards/study programming specific activities independently including collaboration across stakeholders at various timezones 
  • Ensures adherence to high quality programming 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. 
  • Accountable for multiple projects/ongoing work activities (timelines, work plans, deliverables) of moderate complexity within a Work Team 
  • Accountable for their assigned work supporting the standards/study deliverables and also to assist SDSL’s with the team assignments. 
  • Review/Develop/Validate/Review datasets, TFL as per CDISC aligned Pfizer Standards or Pfizer Data Standards for Study/Project/Portfolio. (Portfolio) 
  • Contributes to upto 80% of their time to programming deliverables assigned within the scope of the function in either SAS, R or Python and 20% to self learning, development and growth. 
  • 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 for all of their programming deliverables across Standards, Programming and Submissions. 
  • Understand/Implement standard/study/project/portfolio requirements and 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 complex problem solving skills, seeking direction when appropriate. 
  • Regularly update leads on progress and time estimations to ensure smooth daily operations and accurate planning 
  • Support in accomplishing department and organization mission by completing assigned tasks 
  • Acts as mentor to junior team members 
  • 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. 
  • At least 5 - 6 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency. 
  • Understanding of clinical data and drug development process, CDISC standards required 
  • Statistical Programming and SAS hand-on experience 
  • Clinical trials expertise with 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 to work with stakeholders across timezones under tight timelines 
  • Strong written and oral communication skills, and time and project management skills 
  • Strong competencies and interests for innovation and problem solving 
  • Proven ability to operate with limited oversight 
  • Knowledge of at least 1 Therapeutic Area 

Work Location Assignment: Flexible

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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Confirmed 6 hours ago. Posted 30+ days ago.

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