Sr. Advisor - Statistics
Eli Lilly and Company
4 months ago
Remote friendly (Indianapolis, IN)
United States
$166,500 - $244,200 USD yearly
Clinical Research and Development
Purpose
- Develop or assist in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, clinical research scientists, and other research colleagues.
- Work with research associates and scientists to establish a reporting database and analyze data for clinical studies.
Primary Responsibilities
Statistical Trial Design and Analysis
- Provide input on study protocol and design; write protocols for study conduct.
- Select statistical methods for data analysis; author protocol sections and the statistical analysis plan; conduct analyses once a reporting database is created.
- Collaborate with data sciences to plan and implement data quality assurance plans.
- Maintain currency in statistical methodology; apply new methods; justify selected methods.
- Perform peer-review of statistical colleagues’ work products.
- Influence team members regarding appropriate research methods.
Communication of Results and Inferences
- Collaborate to write reports and communicate results.
- Communicate study results via regulatory submissions, manuscripts, and oral presentations; present in group settings and one-on-one with key customers; present at scientific meetings.
- Respond to regulatory queries and interact with regulators.
Therapeutic Area Knowledge
- Understand disease states, competitive landscapes, and the regulatory environment to enhance customer focus and scientific contribution.
Regulatory Compliance
- Perform work in full compliance with assigned curriculum(s) and follow applicable corporate, medical, local, and departmental policies, procedures, processes, and training.
Statistical Leadership and Teamwork
- Introduce and apply innovative methodology and tools to solve critical problems.
- Merge scientific thinking and business knowledge to identify issues, evaluate options, and implement solutions.
- Lead projects independently; work across functions; apply technical expertise to influence business decisions.
Minimum Qualification Requirements
- Ph.D. in Statistics OR Biostatistics with at least 3 years of experience in Clinical Research and Development.
Other Information / Additional Preferences
- Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUGs, etc.
- Interpersonal communication skills for effective customer consultation.
- Teamwork and leadership skills.
- Technical expertise and working knowledge of experimental design and statistical analysis.
- Self-management skills to deliver timely and accurate results across competing deliverables.
- Resource management skills.
- Creativity and innovation; demonstrated problem solving and critical thinking.
Benefits (if explicitly included)
- Eligibility for a company bonus (depending on company and individual performance).
- Comprehensive benefit program for eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation; medical/dental/vision/prescription drug; flexible benefits (healthcare/dependent day care FSA); life insurance/death benefits; certain time off and leave of absence; well-being benefits (employee assistance, fitness benefits, employee clubs/activities).
- Develop or assist in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, clinical research scientists, and other research colleagues.
- Work with research associates and scientists to establish a reporting database and analyze data for clinical studies.
Primary Responsibilities
Statistical Trial Design and Analysis
- Provide input on study protocol and design; write protocols for study conduct.
- Select statistical methods for data analysis; author protocol sections and the statistical analysis plan; conduct analyses once a reporting database is created.
- Collaborate with data sciences to plan and implement data quality assurance plans.
- Maintain currency in statistical methodology; apply new methods; justify selected methods.
- Perform peer-review of statistical colleagues’ work products.
- Influence team members regarding appropriate research methods.
Communication of Results and Inferences
- Collaborate to write reports and communicate results.
- Communicate study results via regulatory submissions, manuscripts, and oral presentations; present in group settings and one-on-one with key customers; present at scientific meetings.
- Respond to regulatory queries and interact with regulators.
Therapeutic Area Knowledge
- Understand disease states, competitive landscapes, and the regulatory environment to enhance customer focus and scientific contribution.
Regulatory Compliance
- Perform work in full compliance with assigned curriculum(s) and follow applicable corporate, medical, local, and departmental policies, procedures, processes, and training.
Statistical Leadership and Teamwork
- Introduce and apply innovative methodology and tools to solve critical problems.
- Merge scientific thinking and business knowledge to identify issues, evaluate options, and implement solutions.
- Lead projects independently; work across functions; apply technical expertise to influence business decisions.
Minimum Qualification Requirements
- Ph.D. in Statistics OR Biostatistics with at least 3 years of experience in Clinical Research and Development.
Other Information / Additional Preferences
- Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUGs, etc.
- Interpersonal communication skills for effective customer consultation.
- Teamwork and leadership skills.
- Technical expertise and working knowledge of experimental design and statistical analysis.
- Self-management skills to deliver timely and accurate results across competing deliverables.
- Resource management skills.
- Creativity and innovation; demonstrated problem solving and critical thinking.
Benefits (if explicitly included)
- Eligibility for a company bonus (depending on company and individual performance).
- Comprehensive benefit program for eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation; medical/dental/vision/prescription drug; flexible benefits (healthcare/dependent day care FSA); life insurance/death benefits; certain time off and leave of absence; well-being benefits (employee assistance, fitness benefits, employee clubs/activities).