1+ months

Senior Statistical Programming Lead (Sr. Manager)

Hartford, CT 06103
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+ This role is the CDISC submission programming point of contact for teams at the asset, indication, or study level.Could have accountability for multiple indications or studies depending on size

+ Ensures excellence in the delivery of CDISC electronic submission 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 CDISC programming standards in the production of submission documentation


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

+ Accountable for the quality and timely delivery of datasets and deliverables required for health authority submissions needed based on , submissions plan and Study Data Standardization Plan(SDSP) 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 and CDISC compliant specifications for programmed deliverables are in place.

+ Will be knowledgeable in CDISC and electronic submission requirements, core safety standards as well as Therapeutic Area standards pertinent to study projects, 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.

+ Will be a mentor to more junior colleagues


+ 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.

+ 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

+ CDISC and Pinnical 21 Enterprise experience required

+ 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, CDISC 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

This role can be located at our sites in Groton CT, Peapack NJ or Collegeville PA

Employee Referral Eligible


**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.

Posted: 2019-12-13 Expires: 2020-06-04
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Senior Statistical Programming Lead (Sr. Manager)

Hartford, CT 06103

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