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Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

The Sr. Principal Computational Statistician will coordinate and manage development, support, and maintenance of R functions, SAS Macros, and tools/apps for the purposes of supporting and instantiating standards in the clinical development space from data collection through reporting and submission.

The main focus of this role will be to supervise the global implementation of Analysis Results Datasets (ARDS) and Tables, Figures, and Listing (TFL) standards and strategic projects where reusable code concepts are applied. Additionally, this role is responsible for fulfilling 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, ARDS, TFLs, ODM).

Influence, guide, and develop Lilly’s coding strategy for implementing ARDS and TFL standards with R and SAS.

Influence and develop comprehensive and inter-connected tools to facilitate data flow through various parts of the clinical development space.

Be responsible for providing technical leadership and ownership for statistical standards across the clinical trial dataflow.

Assist in and/or be accountable for selecting statistical methods for data analysis, determining and justifying the most proper R package.

Maintain proficiency with respect to statistical programming and methodology while applying it in new and varied methods.

Effectively justify methods selected and coordinate implementation in reusable code.

Conduct peer-review of work products from statistical colleagues.

Effectively apply 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

Drive strategy and resourcing in conjunction with departmental needs and initiatives (ARDS, R usage, TAFFY, etc);

Work with study teams and leadership to effectively align and manage resources in accordance with deliverables and timelines.

Communication of Results and Inferences:

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

Engage with 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 be responsible for following applicable corporate, medical, local, and departmental policies, procedures, processes, and training.

Minimum Qualifications

Master’s degree or above in a Statistics, Biostatistics, or Computer Science-related field PLUS minimum 5 years' experience in clinical data management, data standards, IT or statistics.

Proficiency in both R and SAS

Other Information/Additional Preferences

Experience in implementing pharmaceutical industry standards such as ICH guidelines, SDTM, ADaM, ARS, CDISC, CDASH, etc.

Proficiency in other statistical programming languages/software such as WinBUGS, Python, Spotfire, etc

Interpersonal/teamwork skills for effective interactions.

Experience in and promoting standard methodologies related to building reusable code.

Technical growth and application with solid understanding of statistical software

Self-management skills with a focus on results

Creativity and innovation

Demonstrated problem solving ability and attention to detail

Data analysis, technology and systems expertise

Leadership and project management skills – ability to prioritize and delegate projects

Experience in modeling information or metadata

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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