Senior Statistical Programmer Safety Biometrics

Seattle Genetics - Bothell, WA

Posted: 11/16/2019 - Expires: 12/16/2019

Job ID: 213799043

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Job Description

Seattle Genetics

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
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Biometrics . Bothell, Washington | South San Francisco, California

Description
Summary:
Designs, develops, and modifies SAS programs to analyze and evaluate clinical data with an emphasis on safety signal detection and risk evaluation. Recognizes inconsistencies and initiates resolution of data problems. Provides subject matter expertise in review of key study and project documents and analysis or data set specifications. Acts as a liaison between clinical, drug safety, and study programming teams as needed. Writes, tests, and assists with the standardization of programs and utilities up to the departmental level. Writes requirements and specifications with consideration of cross-protocol consistency, participates in the creation of study- or project-level documentation, and assists with the setup of new studies and/or analyses. Ensures adherence to regulatory and company standards at the protocol level. Provides support for ongoing regulatory and safety reporting needs for regulatory submissions and internal decision-making.

Responsibilities:

Independently develop and validate SAS® programs to produce high-quality datasets, tables, listings, and figures within set timelines in accordance with company and regulatory requirements
Independently implement routine and non-standard analysis algorithms for assigned projects or studies
Provide statistical programming support for one or more studies or projects
Under supervision of a Manager or above, may function as the lead programmer on a study or other end-to-end programming project
Ensure compliance with company and industry standards
Contribute to data set or TFL specifications for assigned projects or studies, or decide on project- or study-level implementation if functioning as lead programmer, under supervision of a Manager or above
Review and provide feedback on deliverables from other clinical groups including but not limited to statistical analysis plans; table, listing, and figure shells; data management plans; data transfer plans; and case report forms
Clear and proactive communication with study and project teams to clarify requirements and specifications, update others on assignment status, and convey data irregularities.
Participate in or lead initiatives that facilitate standards, infrastructure, and process enhancements across Biometrics
Train and mentor new and junior programmers

Qualifications:

7+ years (BS) or 5+ (MS/PhD) of SAS programming experience in the Biotechnology, Pharmaceutical, Medical Device, and Healthcare industries
5+ years of experience in performing statistical programming using SAS® for creating and testing analysis datasets, tables, listings, and figures for Phase I-IV clinical studies
3+ years of experience in writing SAS macros
Advanced SAS® skills
Demonstrated proactivity and strong attention to detail
Good understanding of and hands-on experience with CDISC SDTM and ADaM standards
Experience in performing safety data integration and safety reporting to support signal detection and risk evaluation
Strong understanding and experience in working with MedDRA and WHODrug coding dictionaries
BS, MS, or PhD

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

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PI115543087

Job Summary

Company Details

Company: Seattle Genetics
Industry: Research and Development in Biotechnology

Job Information

Location: Bothell, WA
Job Type: Full Time Employee
Job Position: 1 Position(s) Open
Duration: Over 150 Days

Additional Information

Federal Contractor: No
Affirmative Action Plan: No

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