Pfizer Senior Statistical Programming Lead (Standards) Sr. Manager in Groton, Connecticut

ROLE SUMMARY

  • Works with department leadership and project teams to establish strategy, timelines, and resourcing of statistical programming and analysis deliverables within their area

  • Accountable for the quality and timely delivery of enterprise level standard statistical programming encompassing the following areas: CDISC SDTM, ADaM, and TLF generation

  • Accountable for the management and delivery of prioritized endpoints

  • Responsible for ensuring that all project management and metrics are accurate and up to date

  • Provide oversight and guidance to Pfizer SPA standards programming team and contract resources

  • Manage budget and vendor resources applied to the development of standards

  • Experience working through the development and release process outlined within the standards software development lifecycle (SDLC) practices and SOPs

  • Ensures appropriate documentation is generated to support audit readiness in defense of our standard software development

  • Works with statisticians, programming resources, and other colleagues as appropriate to ensure clear specifications for the standard software development

  • Ensures excellence in the understanding of CDISC IG requirements, NCI Control Terminology, and programming of analysis ready datasets, tables, listings, and figures for which they are responsible

  • Ensures adherence to Pinnacle 21 CDISC validation checks and high quality programming standards in their daily work

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

ROLE RESPONSIBILITIES

  • May have people management responsibilities

  • Will be a mentor to more junior colleagues

  • Accountable for the quality and timely delivery of enterprise, study and asset level deliverables of standard statistical programming encompassing the following areas: CDISC SDTM, ADaM, and TLF generation

  • Ensures that software development lifecycle practices are followed and document as specified by our SOPs and best practices

  • Ensures appropriate documentation is generated to support audit readiness in defense of our standard software development

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

  • Excellent communication skill to ensure appropriate collaboration with statisticians, data managers, statistical programmers, clinical pharmacology leads, research data scientists and programming leads to ensure clear specifications for their programmed deliverables are in place

  • Will be knowledgeable of software development practices as defined within Pfizer's CDISC development framework

  • Provides solutions to complex programming issues using problem solving skills and previous experience

  • Represents Programming Standards into Global Clinical Data Standards Governance Board

QUALIFICATIONS

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

  • At least 8 years relevant CDISC statistical/clinical programming experience in a pharmaceutical, biotech, CRO, or Regulatory Agency

  • Statistical Programming and SAS hands-on experience

  • Clinical trials data flow expertise from data collection through reporting

  • Clinical trials expertise with a thorough understanding of the drug development process and data operations required for the reporting of clinical trial data (e.g. study reports, regulatory submissions, safety updates, etc.)

  • Understanding of clinical data and relevant data standards

  • Thorough knowledge of ICH guidelines and regulatory requirements

  • Knowledge of vendor processes and best practices in outsourcing and oversight

  • Experience working with a global programming team for necessary deliverables

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

  • Strong written and oral communication skills, leadership, decision making, influencing, negotiation, and project management skills

  • Proven ability to operate independently in ambiguous situations

  • Proven ability to present technical information to a non-technical audience

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

  • Ability to manage customer expectations, anticipate potential objections, and influence others

  • Extensive knowledge of statistical methodology and its application to programming

  • CDISC SDTM and ADaM development experience required

  • Pfizer CDARS experience desired

  • Pfizer Standard Software Development Framework experience desired

EEO & Employment Eligibility

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.

Sunshine Act

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