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Statistical Programming Manager


San Francisco, CA
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Job Details

Role Description

EMPLOYER: Pfizer Inc.

TITLE: Statistical Programming Manager

RATE OF PAY: $149,640/year

LOCATION: San Francisco, CA

DUTIES: Address programming related study deliverables. Assist in the review of key study-related documents produced by other functions and other clinical documents. Write, test validate SAS programs to produce analysis datasets, TLGs (Tables, Listing and Graphs) and presentation outputs to be included in reports for submission to regulatory agencies, publications and other communications. Write CDISC standard data set specifications and follow specifications to create ADaM Efficacy and Safety datasets. Represent Statistical programming at study management team and clinical development meetings to address deliverables and timelines. Write, test validate product and study level macros and utilities. Provide ad-hoc or publication requests from medical affairs or clinical operations in supporting the development of clinical trials life cycle. Create submission required ADaM metadata and Define document by using FDA approved application. Assist in the review of Statistical programming policies, SOP and other controlled documents.

Educational Requirement: Master's degree or foreign degree equivalent in Computer Science, Statistics, Mathematics, Life Sciences or related scientific field.

Experience Requirement: 5 years of experience in the job offered or a related occupation.

Alternate Education/Experience Requirements: In the alternative, we will accept a Bachelor's degree or foreign degree equivalent in Computer Science, Statistics, Mathematics, Life Sciences or related scientific field plus 7 years of post-baccalaureate progressive experience in the job offered or a related occupation. Any suitable combination of education, experience or training is acceptable.

Special Skills Requirements: 1) Experience in CDISC standards (CDASH, SDTM, ADaM and SHARE); 2) SAS programming experience in delivering complex programming assignments and analysis; 3) Experience in oncology trials; 4) Experience in FDA/EMEA/PMDA trials and regulatory submissions; 5) Creating scripts or SAS macros to automate analysis reports; 6) Experience in writing excel macros using VB.NET to automate tracking processes; 7) Experience in identifying required changes, developing scripts and testing for migration from Windows to Linux/Unix environment.

This notice is provided in compliance with 20 CFR 656.10(d). Any person may provide documentary evidence bearing on the application to the Certifying Officer of the U.S. Department of Labor, Employment & Training Administration, Harris Tower, 233 Peachtree Street, Suite 410, Atlanta, Georgia 30303.

**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.

**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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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