Pfizer Senior Statistical Programming Lead (Sr. Manager) in Remote, Pennsylvania
This role is the programming point of contact at the asset, indication, or study level. Could have responsibility for multiple indications or studies depending on size
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 submission documentation
May have people management responsibilities
Will be a mentor to more junior colleagues
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 datasets and displays required for clinical study reports, submissions, product defense and commercial support based on analysis plans through management of internal resource or oversight of external resources.
Ensures appropriate documentation across the lifespan of the study and asset 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 serve on a data standards board, and most likely will be leading implementation and potentially development of standards in their project area.
Responsible for managing issues at the study level as they arise and proactively communicating larger asset or general programming issues to management while serving to provide solutions.
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.
Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.
At least 8 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 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 in leading a remote 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 highly desirable.
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.
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.
- Pfizer Jobs