EC
Eli Lilly and CompanyClinical Research Scientist – Breast Cancer Franchise
Clinical Research Scientist developing innovative breast cancer therapies at Lilly. Collaborating with cross - functional partners in clinical trial design and execution.
About the role
- Serve as an internal consultant for biostatistics analysis tools and methods
- Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support
- Actively support business development in capabilities presentations to prospective and current clients
- Effectively manage assigned clinical study budgets for biostatistics analysis support
- Develop, coach and mentor junior biostatistics department personnel
- Act as the lead statistician on clinical research projects and help with SAS programming
- Provide statistical expertise for study design of clinical trial protocols
- Write statistical methods section of the study protocol, as needed
- Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed
- Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP)
- Program summary tables, data listings and graphical representations of clinical trials data
- Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data
- Prepare/review key sections of clinical study reports and various regulatory documents
- Perform statistical QC of all department outputs including analyses and clinical study reports
- Provide statistical support to answer questions from external clients (such as FDA, Investigators)
- Contribute to the development, maintenance, and training of standard operating procedures (SOPs)
- Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed
- Manage biostatistics timelines, budgets, and client expectations
- Adhere to all aspects of the Statistics & Data Corporation’s quality system
- Comply with Statistics & Data Corporation’s data integrity & business ethics requirements
- Perform other related duties incidental to the work described herein
- Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements
Requirements
- Effective leadership, budget forecast and implementation skills
- Excellent analytical skills, with the ability to process scientific and medical data
- Able to work independently and in teams
- Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills
- Excellent knowledge of statistical programming
- Expertise in manipulating and analyzing SAS data
- Able to identify data issues, present problems, and implement solutions
- Capable of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues and clients
- Excellent organizational and time management skills, with the ability to multi-task
- Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
- Strong interpersonal communication and presentation skills
- Able to effectively collaborate across cross-functional teams
- Focus on quality at all times and in all situations
- A Master’s degree in biostatistics, statistics or other related, scientific field and at least eight years of relevant professional experience or a combination of education and experience
Benefits
- Competitive pay
- Generous time off
- Attainable career advancement
- Positive work/life balance
- 401k matching (US)
- Flexible work schedule
- Engaging work culture
- Employee benefits
- Recognition program tied to core values
- Career development and growth opportunities
- Fun and engaging activities from SDC’s culture club
- Global, diverse perspectives
- Proven track record executing client clinical programs since 2005
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
SC
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EC
Eli Lilly and Companyクリニカルリサーチサイエンティスト, ニューロサイエンス領域
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