Statistical Analyst - Data Standards
Eli Lilly - Indianapolis, IN

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The Statistical Analyst will coordinate and manage all aspects of statistical analysis of clinical trial data in drug development through innovative strategies, close collaboration with medical colleagues, and quality oversight of external work products.

The primary focus of this role will be to assist with the global implementation of CDISC Standards (SDTM and ADaM). The Statistical Analyst will be charged with providing technical leadership for data standards across the clinical trial dataflow, with the primary focus on ADaM. This includes the development of the ADaM strategy across therapeutic areas. As a member of the ADaM core team the analyst will be accountable for strategic and technical decisions, issue escalation, monitoring compliance, and will act as a representative to the Standards Control Board. Additionally, the analyst will help to define strategies for developing re-usable programs for analysis and reporting. The analyst will also be asked to influence externally to proactively resolve complex standards issues and establish new therapeutic area standards key to Lilly.

KEY OBJECTIVES/DELIVERABLES:
Global Statistical Sciences is comprised of multiple therapeutic areas and based on experience, interest, and need, the analyst will be aligned to one or more of the therapeutic areas, which are:
  • Diabetes/Endocrine, Internal Medicine/Auto immune diseases, Neuroscience, and Oncology.
  • Global implementation of CDISC Standards (SDTM and ADaM); including working with teams to define and develop study specifications, as well as re-usable data standards and code.
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.
MINIMUM REQUIREMENTS:
  • Bachelors degree
  • Knowledge of pharmaceutical industry standards such as ICH guidelines, SDTM, ADaM, CDISC, CDASH, etc.
  • Proficiency in SAS programming language
  • Familiarity with clinical data standards tools and technologies
  • Experience working in an environment that has successfully implemented and maintained re-usable standards and code
  • Ability to articulate the flow of data (structure and format) from patient to analysis and apply this knowledge to data standards development
  • Demonstrated programming knowledge and ability to apply knowledge to the development of standards and/or project deliverables
  • Maintain awareness of new development in statistics and programming techniques.
  • Experience / knowledge of all phases of clinical trials
  • Qualified candidates must be legally authorized to be employed in the United States. Eli Lilly and Company does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Additional Skills/ Preferences:
  • Masters degree in Statistics, Biostatistics, Public Health, Mathematics or in a related field.
  • Aptitude for creativity and innovation
  • Positive and professional approach
  • Clear and constructive communication ability to explain issues clearly
  • Interpersonal/teamwork skills for effective interaction
  • Leadership and project management skills ability to prioritize and delegate projects
  • Organizational and self-management skills with a focus on results for timeline and accurate completion of competing deliverables flexibility
  • Self-motivated identify and resolve problems attention to details
  • Experience working with and managing external vendors and third party organizations
Other Considerations

  • Full-Time
Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. A company rich in heritage, Lilly employs individuals, conducts research and markets products worldwide. By providing for the unmet needs of our customers through a continuous stream of innovation, we will outgrow all competitors.

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Awards and Recognition

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