Statistical Programming Group Lead (Director)

ROLE SUMMARY

• This role is the programming point of contact at the large asset level.Could have responsibility for a cluster of multiple smaller assets
• This role will have full accountability for all the programming deliverables under their asset(s).
• This role will have direct management responsibilities of a team of 5-8 programmers and possibly programming leads.
• 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 at the asset level.
• Ensures adherence to high quality programming standards in the production of clinical reports and submission documentation at the asset level.

ROLE RESPONSIBILITIES

• Will have people management responsibilities
• Will be a mentor to more junior colleagues
• Will be required to travel as needed for department meetings, regulatory needs, and other cases either related to projects or people.
• Works with department leadership to help establish strategy for the programming discipline.
• Works with asset 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 leadership, and guidance of internal and external resources.
• Responsible for planning all programmed deliverables including consideration of special data types and downstream uses of data as well as contributing to the asset level/submission strategy.
• Works with other asset level leads across statistics, clinical, regulatory and other colleagues as appropriate to ensure clear specifications for programmed deliverables are in place.
• Will be an expert in core safety standards as well as Therapeutic Area standards pertinent to their asset, should serve on the relative TA standards board, and planning implementation and development of standards in their space.
• Will contribute to, and lead department level initiatives.Will also contribute to broader initiatives outside of the department.

QUALIFICATIONS

• Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.
• At least 10 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.
• Expert knowledge of clinical data, regulatory requirements, and relevant data standards
• Knowledge of vendor processes and best practices in outsourcing and oversight
• Experience in leading a programming team for necessary deliverables at the asset level within a matrixed organization
• 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
• Sound knowledge and experience working across international boundaries and cultures.
• Ability to manage customer expectations, anticipate potential objections, and influence others
• CDISC experience highly desirable
• "Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact."

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.

Medical

#LI-PFE