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Senior Biostatistician

0-2 years
Not Disclosed
10 Feb. 11, 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 Biostatistician
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full Time, Regular
Job ID: R-76298

Purpose:

The Senior Biostatistician is responsible for providing statistical expertise in clinical trials by contributing to protocol designs, clinical plans, and data analysis plans. This role works closely with other research associates, scientists, and study personnel to establish reporting databases and analyze data from clinical studies.

Key Responsibilities:

  1. Statistical Trial Design and Analysis:

    • Collaborate with study personnel to provide input on study protocols, and design studies, including writing protocols for the conduct of studies.
    • Assist in or be accountable for selecting statistical methods for data analysis, authoring sections of the protocol, and conducting analysis once the reporting database is created.
    • Work with data management teams to plan and implement data quality assurance plans.
    • Stay current with statistical methodologies, applying new techniques, and ensuring proficiency in the methods used.
    • Participate in peer-review of work products from other statistical colleagues.
  2. Communication of Results and Inferences:

    • Collaborate with team members to write reports and communicate study results.
    • Contribute to communicating study results via regulatory submissions, manuscripts, and oral presentations in group settings.
    • Assist in responding to regulatory queries and interact with regulators as required.
  3. Therapeutic Area Knowledge:

    • Deepen understanding of disease states to enhance customer focus and contribute as a scientific expert.
  4. Regulatory Compliance:

    • Perform work in full compliance with corporate, medical, local, and departmental policies, procedures, processes, and training.

Minimum Qualification Requirements:

  • Educational Background:
    • M.S. or Ph.D. in Statistics, Biostatistics, or a related field.
    • More than 3 years of relevant experience in biostatistics or statistics.

Additional Skills and Preferences:

  • Proficiency in the SAS programming language.
  • Strong interpersonal communication skills for effective collaboration and consultation with customers.
  • Proven teamwork and leadership abilities.
  • Technical knowledge in experimental design and statistics.
  • Strong self-management skills and ability to deliver results under deadlines.
  • Demonstrated problem-solving ability and strategic thinking.
  • Resource management and creativity in developing solutions.
  • Business process expertise for critical activities like regulatory submissions.

Additional Information:

  • Lilly is committed to providing accommodations for individuals with disabilities to actively engage in the workforce. Please complete the accommodation request form for assistance with the application process.

  • Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

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