Pfizer - Principal Statistical Programmer

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.

- 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

- Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.

- At least 5 - 6 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.