Position Vacant for:
Title- Senior Scientist, Statistics & Quantitative Sciences
Job ID- 50451327
Location- New Jersey – Branchburg. 08876
General Summary:
Provide statistical analysis and expertise to groups within the Biopharm Ops and Quality organizations. Consultant to management and scientific project and regulatory teams.
Develops statistical methodologies and software. Provide direction on efficient, rigorous experimental plans. Provide timely analysis on key studies, and provide support for regulatory documentation. Defend these initiatives for statistical validity to agency regulators.
Primary Responsibilities:
Propose and defend statistical approaches Develop and defend reports, study protocols 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 relevant industry trends and guidance. Support analytical method development, optimization and qualification/validation. Provide guidance (including SOPs) on process monitoring and statistical quality control methodologies that are integrated with business practices. Develop statistical modules and tools as needed to improve overall quality and efficiency of manufacturing and testing. Utilize scientific and technical background beyond statistical expertise to aid in the understanding of problems being addressed by the technical functional groups. Provide training and guidance in the appropriate use of statistical methodology. Assist with the preparation of regulatory documents (such as sBLA and BLA).Provide supervision as appropriate to internal and contract personnel. Provide leadership and stewardship for championing statistical and scientific excellence in all of these activities.
Knowledge/Skills/Education:
- A minimum of an MS in Statistics +7 years’ experience, or PhD + 3-5 years.
- Very strong statistical knowledge set.
- Capable of defending work in front of regulatory agencies.
- Demonstrated in depth knowledge of statistical software such as S-plus, R and SAS.
- In-depth knowledge (or a technical degree) in area such as chemistry, biochemistry or engineering a plus.
- Demonstrated ability to work across functional area(s).
- Knowledge and experience working with database systems.
- Extensive experience with GxP systems.
- Excellent oral and written communication skills
- Master’s Degree (or equivalent work experience) Full-Time
Apply Online at:
To apply go to: http://www.imclone.com/careers_imclone.html
Search job using Title- Senior Scientist, Statistics & Quantitative Sciences or Job ID: 50451327
Company Description:
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company (NYSE:LLY), is committed to advancing oncology care by developing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers. Founded in 1984, ImClone has a rich culture of discovery and deep expertise in oncology. ImClone has several investigational monoclonal antibodies in various stages of clinical development. ImClone’s research and clinical development capabilities are augmented by its expertise in the scale-up and manufacturing of biologics. The company’s state-of-the-art FDA-approved manufacturing facilities provide it with one of the largest biologic manufacturing capacities in the world.