ROLE SUMMARY 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 This role is the programming point of contact at the study level, and will support at the asset/submission level. Ensures adherence to high quality programming standards in the production of clinical reports. ROLE RESPONSIBILITIES 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 across the lifespan of the study for all programming deliverables and verifies proper Trial Master File filings when appropriate. Ensures planning is in place for all programmed deliverables including consideration of special data types and downstream uses of data 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. 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 Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field. At least 5 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 CDISC experience highly desirable. Additional Details: Eligible for Employee Referral Bonus Can be remote based Grade 10 Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. 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All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.