Sr. Statistical Programming Lead (Standards), Associate Director

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-REMOTEPfizer 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 ActPfizer 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 EligibilityPfizer 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.Medical