Pfizer Programming Lead in Groton, Connecticut

A career at Pfizer offers opportunity, ownership and impact.

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 biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

• This role is the programming point of contact at the individual study level and may be responsible for multiple studies within or across assets.

• Ensures excellence in the delivery of analysis ready data sets, tables, listings and figures, in order to advance research, development, and commercialization of the Pfizer portfolio.

• Ensures adherence to high-quality programming standards in the production of clinical reports, and submission documentation.

• Establishes strategy, timelines, resourcing and project management for the analysis and reporting of clinical study data working with drug development project teams and department leadership.

• Accountable for quality and timely delivery of standard and non-standard data sets, tables, listings and figures that are required for the study reports, submissions and product defense and commercial support based on the final protocol synopsis and statistical analysis plan.

• Ensures appropriate documentation across the lifespan of the study and asset for all programming deliverables, and verifies the proper TMF filings, as appropriate, to ensure accurate records supporting oversight and quality for inspection readiness.

• Ensures planning is in place for all programmed deliverables, including consideration of special data types (e.g., adjudicated endpoints, biomarkers, PK/PD data, patient-reported outcomes, non-CRF data, serology lab results) and potential down-stream uses of data.

• Works with programmers, statisticians and others to clarify points of ambiguity to ensure clear, concise, complete specifications for programmed deliverables.

• Works with programming vendor to ensure the right resources are assigned to produce programmed deliverables. Regularly meets with programming vendor lead/team to establish and document quality control steps to be performed and documented prior to delivery of final output, and ensure alignment and progress to deliverable milestones.

• Supports understanding of Pfizer Data Standards and analysis plan requirements and ensures strategy for data standard implementation is followed (e.g. CDISC or PDS)

• Provides statistical programming SME support to Development Operations and Therapeutic Area communities.

• Bachelor or Master 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 clinical trials expertise with a thorough understanding of the processes associated with clinical drug development and data analysis operations required for the reporting of clinical trial data (e.g. study reports, safety updates, global regulatory submissions, etc.).

• Adept at solving problems using skills based on experience and extrapolation to new situations

• Understanding of clinical data, regulatory requirements and relevant data standards.

• Knowledge of vendor processes and best practices in outsourcing.

• Strong communication (written and oral), leadership, decision-making, influencing, negotiation, and project management skills.

• Hands-on statistical programming and SAS experience.

• Demonstrated experience managing complex projects and developing successful partnerships within study or asset teams.

• Proven ability to operate independently in ambiguous situations.

• Sound knowledge and experience working across international boundaries and cultures.

• Able to manage customer expectations, anticipates potential objections and influences others.

• CDISC experience desirable.

PHYSICAL/MENTAL REQUIREMENTS

Position located at Development Operations site or remote work location. Primarily an office-based position involving computer work, attending meetings, making presentations, participating in global conference calls that accommodate time zones, etc.

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.

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Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.A career at Pfizer offers opportunity, ownership and impact.

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.