Principal Scientist

Company Name:
Eli Lilly
Company Overview:
ImClone Systems LLC is a leader in therapeutic monoclonal antibodies and committed to changing the world of cancer care by developing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of tumor types. Founded in 1984, ImClone has a rich culture of discovery and deep expertise in oncology. Following its acquisition by Eli Lilly and Company in 2008, ImClone is accelerating its antibody pipeline development by leveraging Lilly's global capabilities. ImClone's pipeline has several molecules in mid- to late-stage clinical development targeting a variety of cancers.
Responsibilities:
A senior level statistical expert who provides statistical leadership in crosses functional teams. An individual capable of working effectively a wide set of functional groups including product development, QC, regulatory, and manufacturing operations.
Nature of the Work:
Statistical Team Leader
Serve as statistical lead on project teams.
Provide experimental design and analysis support in product development scientists to design and optimize manufacturing process steps and formulations.
Provide design and analysis of stability studies for determining release and shelf-life specifications and expiry dating
Collaborate with scientists and statisticians on applied research projects related to modeling, experimental design, process control, and/or multivariate analysis.
Provide supervision as appropriate to internal and contract personnel.
Develop and defend master study and analysis plans.
Work with groups such as Development, QC, and Manufacturing to establish statistical methodologies for efficient test design, policies, and procedures (for example test method transfer protocols and acceptance criterion).
This includes being aware of industry trends and guidance.
Author SOP and reports as required.
Regulatory Statistical Lead
Propose and defend statistical approaches to regulatory agencies.
Author sections of regulatory (CM&C Chemistry, Manufacturing and Control) submission documents for successful product approval throughout the world
Assist with the preparation of regulatory documents.
These include documents like sBLAs, BLAs INDs, Briefing Documents, and questions as they arise from regulatory authorities.
Lead scientists on statistical technical choices
Enlist support from scientific opinion leaders or senior management to influence ideas or plans and effectively present them to them to internal management governance forums.
Basic Qualifications:
Ph.D. in Statistics or a related field and at least 6 years industrial experience, or an M.S. in Statistics and at least 10 years industrial experience
Additional Skills/Preferences:
Extensive scientific knowledge or dual degree (engineering, chemistry, biology) along with statistics is a plus.
Ability to lead statistical efforts as an effective member of a cross functional teams.
Ability to influence the use of statistical and technological tools to improve efficiency and quality of work products.
Strong applied/technical/statistical background with the ability to defend statistical output in front of regulatory agencies.
Demonstrated knowledge of statistical software such as S-plus, R and SAS.
Enjoy working with people
Strong leadership skills
Ability to work in a self-managed environment within a small team of statisticians
Excellent written and oral communication skills.
Additional Information:
Eli Lilly and Company, Lilly USA LLC, affiliates and our wholly owned subsidiaries including ImClone Systems (collectively, Lilly) are EEO/Affirmative Action Employers, and do not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status.
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