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Pfizer Sr. Statistical Programming Lead (Standards), Associate Director in Groton, Connecticut

Role Summary:

  • This role is the programming point of contact at the standard, domain, or therapeutic area level.

  • Ensures 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.

  • In addition to management of the deliverables, the senior lead will also provide consultation to the asset/submission teams with respect to planning of programmed asset deliverables as well as standards strategy

  • Ensures adherence to high quality programming standards in the production of clinical reports and ADaM datasets

Role Responsibilities:

  • 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

  • In-depth knowledge of Pfizer's standards development framework and CDARS reporting environment

  • 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

  • Will 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

  • Will contribute to, and may lead department level initiatives. May also contribute to broader initiatives outside of the department

  • 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 10 years relevant statistical/clinical programming experience in a pharmaceutical, biotech, CRO, or Regulatory Agency

  • Statistical Programming and SAS hands-on experience

  • Knowledge of R is highly desirable

  • 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.)

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

  • 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 experience required

  • Pfizer CDARS experience required

  • Pfizer Standard Software Development Framework experience desired

  • Real World Data & Evidence experience desired

#LI-PFE

#LI-REMOTE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.

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