QUALIFICATIONS / SKILLS

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• Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.
• At least (8-15) years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.
• Statistical Programming and SAS hands-on experience
• 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

• 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.