This role involves statistical programming and project lead responsibilities, mentoring, collaboration with clinical teams, and adherence to quality standards in programming for clinical studies.
- An Individual Contributor role
- Productive h ands 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 S DS L'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/ s tudy deliverables and also to assist S DS L's with the team assignments.
- Review/ Develop/ Validate /Review datasets, TFL as per CDISC aligned Pfizer Standards or Pfizer Data Standards for Study/Project/Portfoli o. (Portfolio)
- Contributes to upto 8 0% 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, b iological s ciences, 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
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
Top Skills
Cdisc Standards
Python
R
SAS
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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