The role is/includes  

• Individual Contributor/Project or Application Manager/People Manager of small teams 

• A highly productive, independent programming lead ensuring excellence in the delivery of analysis ready datasets, tables, listings, and figures to advance research, development, and commercialization of the Pfizer portfolio following Pfizer SOPs and processes 

• The programming point of contact at the study level, and will support at the asset/submission level (TA and Study) , supporting end to end deliverables in the study/project/portfolio/standards team high complex statistical programming deliverables to support assets and study teams  

• Leading architecture development in Standards for major phases of delivery 

• Manage projects(mid and small sized) and/or manage small sized teams 

• 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 Senior 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 

• Contributes to upto 70% of their time to programming deliverables assigned within the scope of the function in either SAS, R or Python,10% to resourcing, project/people management and 20% to self learning, development and growth.   

• Will deliver through combination of oversight of vendors/offshore support as well as through hands on programming 

• Works with department leadership and project teams to establish strategy, timelines, and resourcing of statistical programming and analysis deliverables for their study(ies). 

• Accountable for the quality and timely delivery of datasets and displays required for their clinical study reports as well as other asset level deliverables they may contribute to under the leadership of the asset lead.  

• Ensures appropriate documentation and QC across the lifespan of the study for all programming deliverables and verifies proper Trial Master File filings when appropriate. 

• 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 planning is in place for all programmed deliverables including consideration of special data types and downstream uses of data 

• Responsible for all deliverables within the project, responsible for assisting the Senior Manager in performance reviews and appraisals and for suggesting career development plans for the team members.  

• Also SME's and leads of initiative at global levels, contributing to global intiatives and projects such as Submission Specialists, Application Manager etc. 

• Works with statisticians, programming resources and other colleagues as appropriate to ensure clear specifications for programmed deliverables are in place. 

• Will be knowledgeable in core safety standards as well as Therapeutic Area standards pertinent to their project, may aid in development of standards necessary for their study.  

• Will contribute to department level initiatives. 

• Acts as mentor to junior team members 

• Advances job knowledge to next level by participating/contributing in/to opportunities both globally and locally.  

• Proactive at communicating potential issues to upper management 

• Anticipates and solves routine problems, while developing the ability to solve complex problems using skills based on experience and extrapolation to new situations 

QUALIFICATIONS / SKILLS 

Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills. 

• Bachelor or Master (preferred) Degree in Statistics, Computer Sciences, Engineering, Pharmacy, biological sciences, IT, or related field. 

• At least 7-8 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency. 

• Clinical trials expertise with a thorough understanding of data operations required for the reporting of clinical trial data.  

• Good understanding of ICH and Regulatory Guidelines  

• Routine problem solving skills, developing the ability to solve complex problems using skills based on experience and extrapolation to new situations.  

• Thorough understanding of clinical data and relevant data standards  

• Extensive knowledge of routine statistical methodology and its application to programming  

• Knowledge of vendor processes  

• Demonstrated experience in developing successful partnerships within study teams  

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

• Ability to present technical information to a non-technical audience  

• Proven ability to operate independently.  

• Some exposure working across international boundaries and cultures.  

• Ability to manage customer expectations.  

• Ability to manage work of others in a remote and/or global setting  

• CDISC experience needed 

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.