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Principal Biostatistician

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Job Summary

Company
Lilly
Location
Indianapolis, IN 46285
Industries
Biotechnology/Pharmaceuticals
Job Type
Full Time
Employee
Years of Experience
5+ to 7 Years
Education Level
Doctorate
Career Level
Experienced (Non-Manager)
Job Reference Code
ELY10692BRM

Principal Biostatistician

About the Job

Company Overview: 

Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees – in competitive salaries, training and development, and health.

The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients. 

If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity. 


Responsibilities:

 


The Principal Research Scientist at this level provides statistical leadership in multiple dimensions including: 


  • Provides technical leadership and expertise in initiating and executing multi-disciplinary or cross functional projects that impact the Lilly Research Laboratory and the Statistical Sciences organization
  • Leads the assessment and introduction of new statistical technology and methodology to apply to broader practice
  • Leads or assists in the development of clinical plans, innovative protocol designs, and statistical analysis plans in collaboration with physicians and/or medical colleagues
  • Provides consulting and statistical direction on priority clinical projects.
  • The job tasks listed below outline the scope of the position. The application of these tasks may vary, based upon current business needs.

 
Statistical Knowledge and Expertise: 

  • Maintain currency with advances in statistical methodology; maintain proficiency in applying new and varied methods and; be competent in justifying methods selected.
  • Drive statistically robust approaches or solutions that increase the probability of technical success, save time, increase efficiency or otherwise directly impact business.
  • Provide sound peer-review of work products from other statistical colleagues, and advise others on technical aspects.
  • Collaborate with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.
  • Assist in or be accountable for selecting the right and innovative statistical methods for data analysis, authoring the corresponding sections of the protocol, 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.
  • Communication, Leadership and Influence
  • Can effectively lead cross-functional or multi-disciplinary groups and use technical expertise to influence business decisions.
  • Collaborate with team members to write reports and communicate results.
  • Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.
  • Respond to regulatory queries and to interact with regulators.
  • Defines or adjusts project objectives to reflect broader strategy and objectives.
  • Pharmaceutical Industry/Therapeutic Area Knowledge
  • Have broad understanding about the drug hunting process.
  • Have deep understanding on disease states in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.
  • Regulatory 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.
  • Optional – As a Group Leader, your responsibilities will include
  • Engaging with leaders in other disciplines to understand business priorities and project deliverables
  • Working with physicians, clinical scientists and select vendors to appropriately prioritize & resource projects
  • Managing, and providing direction, development guidance and technical coaching to your group of statisticians.

 
Basic Qualifications:

  • PhD degree in Statistics/ Biostatistics or related field with at least 5 years of clinical trial experience in pharmaceutical industry.
  • 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.

 
Additional Skills/Preferences: 

  • Interpersonal communication skills for effective customer consultation
  • Deep knowledge of the drug development process (phase I-IV) and/or the Drug Discovery Area
  • Experience in modeling and simulation, adaptive designs, pharmacogenomics and Bayesian statistics
  • Teamwork and leadership skills
  • Self-management skills with a focus on results for timely and accurate completion of competing deliverables
  • Experience in the therapeutic areas of oncology, diabetes, neurosciences, CV, or autoimmune is highly preferred.
  • Resource management skills
  • Creativity and innovation
  • Demonstrated problem solving ability and strategic thinking
  • Business process expertise associated with critical activities (e.g. regulatory submissions)

 
Additional Information:
 

Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status 

 

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