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) and strategic projects where CDISC concepts are applied. Additionally, the Statistical Analyst will be fullfilling the following:
- Influence, define, and instantiate core and therapeutic area standards for broader reusability and drive toward consistency; understand, influence, and incorporate industry standards (CDASH, SDTM, ADaM, ODM).
- Responsible for providing technical leadership and ownership for statistical standards across the clinical trial dataflow.
- 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 statistical programming and methodology while applying it in 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.
- Develop standards for transformations of source data into observed and analysis datasets, including derived variable standards.
- Develop metadata used to automate and control the clinical trial dataflow process
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.
- Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
- Participation on external committees to develop and influence industry standards, processes and tools
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.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
- Master’s degree in Statistics, Biostatistics, Computer Science, Informatics, Mathematics or in a related field
- Experience in clinical data management, data standards, IT or statistics.
- 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
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
- Experience in implementing pharmaceutical industry standards such as ICH guidelines, SDTM, ADaM, CDISC, CDASH, etc.
- Proficiency in statistical programming languages/software such as SAS, R, Spotfire, WinBUG, etc
- Interpersonal/teamwork skills for effective interactions.
- Experience in and promoting best practices around building reusable code.
- Technical growth and application with working knowledge of statistical software
- Self-management skills with a focus on results
- Creativity and innovation
- Demonstrated problem solving ability and attention to detail
- CDISC standards, data analysis, technology and systems expertise
- Leadership and project management skills – ability to prioritize and delegate projects
- Experience modeling information or metadata