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Manager Statistical Programming

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:
Statistical Analysis:
Collaborate with other statistical colleagues and study personnel to provide input to statistical analysis plans.
Assist in and/or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the analysis plan, and conducting the actual analysis once a reporting database is created.
Collaborate with data management in the planning and implementation of data quality assurance plans.
Maintain proficiency with respect to SAS programming and statistical methodology and in applying new and varied methods.
Effectively justify methods selected and implement previously outlined analysis plans.
Conduct peer-review of work products from statistical colleagues.
Effectively utilize current technologies and available tools for conducting the clinical trial analysis.
Communication of Results and Inferences:
Collaborate with other statistical colleagues to write reports and communicate results.
Responsible for assisting in the communication of study results via regulatory submissions, and manuscripts, as well as for communicating one-on-one with key customers.
Assist or respond to regulatory queries working in collaboration with other statistical colleagues.
Therapeutic Area and Systems Knowledge:
Understand relevant disease states in order to enhance the level of customer focus and collaboration.
Ensure replication of tools and systems, where applicable and stay informed of technological advances.
Regulatory and Quality Compliance:
Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable corporate, medical, local, and departmental policies, procedures, processes, and training.
Basic Qualifications:
Masters degree in Statistics or Biostatistics with 3+ years relevant postgraduate experience
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Additional Skills/Preferences:
Proficiency in statistical programming languages/software such as SAS, R, Spotfire, WinBUG, etc.
Interpersonal/teamwork skills for effective interactions
Technical growth and application with working knowledge of statistics and statistical software
Self-management skills with a focus on results for timely and accurate completion of competing deliverables
Creativity and innovation
Demonstrated problem solving ability and attention to detail
Data analysis, technology, and systems expertise
Pharmaceutical industry standards such as ICH guidelines, SDTM, ADaM, CDISC, CDASH, etc., knowledge
Work and manage external vendors and third party organizations and provide oversight to outsourced work.
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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