Principal Statistical Programmer

• Hands on programming role, supporting deliverables in the study/project/portfolio/standards team, of medium or high complex statistical programming deliverables

• Mentored/Guided by Statistical Programming Leads within Standards/Study/Project/Portfolio/TA’s

• Guide, 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 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 SPA initiatives globally and locally.

Responsibilities**:**

• 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 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 milestones

• Ensures 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 planning

• Advances 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 tasks

• Acts 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 experience

• 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

• Ability to Identify and solve complex problems

• Exposure working across boundaries, with various stake holders.

• Strong written and oral communication skills, and project management skills

• Proven ability to operate with limited oversight

• Knowledge of at least 1 Therapeutic Area

• Proven ability to manage delivery under tight timelines.

• CDISC and submission experience desirable.

Location: Chennai or Mumbai

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