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Senior/ Director - Biostatistics

15+ years
Not Disclosed
10 Feb. 25, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:Senior/ Director - Biostatistics

Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full Time Regular
Job ID: R-76298


About Eli Lilly:

Eli Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through the discovery and delivery of life-changing medicines. The company focuses on both advancing scientific knowledge and making a positive impact on communities worldwide.


Position Overview:

The Senior Biostatistician will support the design, analysis, and reporting of clinical trials. Working closely with study teams, this role involves developing protocols, analysis plans, and ensuring statistical methods are applied accurately throughout the lifecycle of clinical studies. The Biostatistician will also contribute to communication efforts, including writing reports and regulatory submissions, and presenting results at scientific meetings.


Key Responsibilities:

  1. Statistical Trial Design and Analysis:

    • Collaborate with study personnel to provide input into study protocols and design.

    • Select appropriate statistical methods for data analysis, author the corresponding sections of the protocol, and execute the analysis once a reporting database is established.

    • Work with data management to plan and implement data quality assurance strategies.

  2. Communication of Results:

    • Assist in writing reports and communicating study findings to both internal teams and external stakeholders.

    • Participate in regulatory submissions, manuscript preparation, and oral presentations.

    • Respond to regulatory queries and engage with regulators as needed.

  3. Therapeutic Area Knowledge:

    • Enhance collaboration and customer focus by understanding relevant disease states.

    • Contribute as a scientific expert within the team.

  4. Regulatory Compliance:

    • Ensure all work complies with corporate, medical, and departmental policies and procedures.


Minimum Qualifications:

  • Education:

    • M.S. or Ph.D. in Statistics, Biostatistics, or a related field.

  • Experience:

    • More than 15 years of relevant experience in the field.

  • Skills and Knowledge:

    • Proficiency in SAS programming.

    • Strong interpersonal communication skills for consulting with customers.

    • Leadership abilities and strong teamwork skills.

    • Demonstrated expertise in experimental design and statistics.

    • Problem-solving ability and strategic thinking.

    • Ability to manage resources and deliver results on time.


Additional Preferences:

  • Experience in regulatory submissions and business processes associated with them.

  • Ability to innovate and apply creative solutions to problems.


Additional Information:

  • Commitment to Inclusion: Lilly is dedicated to creating an inclusive work environment where individuals with disabilities can actively engage in the workforce.

  • Accommodation Requests: If you require accommodation to submit your resume for this position, please complete the accommodation request form.


How to Apply:

For more details and to apply, visit the Eli Lilly Careers page.