Pfizer
Website:
pfizer.com
Job details:
Job Summary
- 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 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 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.
Job Responsibilities :
- Accountable for their assigned work supporting the standards/study deliverables
- 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.
- Review/Develop/Validate datasets, TFL as per CDISC aligned Pfizer Standards or Pfizer Data Standards for Study/Project/Portfolio (TA or Study Programming)
- 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/Develop/Review standard/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 complex problem solving skills, 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 standards required
- Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data.
- 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
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
Click on Apply to know more.