Summary
The Data Engineer (Statistics/Bioinformatics) role reports to the Principal Scientist, CMC Statistics, in the Data Science group within the Technical Operations and Process Sciences (TOPS) division. This position will provide statistical thinking to potency assay, analytical, and formulation development, the quality organization, and manufacturing group. This role will include assisting scientists and other professionals to develop experimental designs and understand their data, and to execute SAS code to generate technical reports for our business partners. This role will involve extensive collaboration with stakeholders within the Data Science team, as well as across Seagen’s IT, Process Sciences, Manufacturing, Quality, and Product Supply teams. The successful candidate must be a high-performing team player with strong communication skills who thrives in a fast-paced environment.
Principal Responsibilities
- Provide statistical expertise to multiple CMC areas, including development, quality, and manufacturing
- Propose experimental design and analysis strategies, perform statistical analyses, and collaborate to ensure the statistical integrity of data in development and GMP manufacturing
- Support product and process monitoring in GMP manufacturing
- Support regulatory submissions and investigations
- Build strategic partnerships with collaborators and promote statistical thinking in decision making
- Explain statistical outputs to Scientists to facilitate adoption/buy-in
- Ensure sound data management practices
- Keep current with new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and professional activities
Required Qualifications
- B.A or BSc degree in statistics, applied mathematics, or a related field.
- Minimum of 5 years of relevant work experience
- Proficiency in SAS programming
- Experience with JMP, Minitab or similar statistical software
- Experience with experimental design strategies, statistical process control, capability analysis, and other aspects of engineering statistics
- Confident, energetic self-starter, with strong moderation and communication skills to simplify complex topics for stakeholders to understand the benefits of Data Science
- Demonstrated ability to work in diverse, cross-functional teams in a dynamic business environment.
- Excellent written communication skills
- Biopharmaceutical industry experience
Preferred Qualifications
- Experience in combining statistical methodologies with machine learning techniques in the execution of far-reaching data solutions unique to the CMC pharmaceutical industry
As the leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visit www.seagen.com.
Seagen 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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