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Principal Statistical Programmer

2+ years
Not Disclosed
10 March 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Principal Statistical Programmer
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full Time, Regular
Job Id: R-82480

Purpose:
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work globally to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

Primary Responsibilities:

Programming and Data Analysis:

  • Support all programming activities required for the data analysis of clinical trials.

  • Create standard datasets (SDTM) and analysis datasets (ADaM).

  • Generate reports, including Tables, Listings, and Graphs, as applicable.

  • Support documentation tasks such as Define, RGs, and CRT packages for clinical trial reporting.

  • Collaborate with statistical colleagues and study personnel to provide input to statistical analysis plans.

  • Assist in or be accountable for selecting statistical methods, authoring corresponding sections of the data analysis plan, and conducting analyses once the reporting database is created.

  • Collaborate with data management in planning and implementing data quality assurance plans.

Technical Expertise and Methodology:

  • Maintain proficiency in SAS programming and statistical methodology.

  • Apply new and varied methods effectively, justifying the selected methods.

  • Conduct peer reviews of work products from statistical colleagues.

  • Utilize current technologies and available tools for conducting clinical trial analysis.

Communication of Results and Inferences:

  • Collaborate with statistical colleagues to write reports and communicate results.

  • Assist in communicating study results through regulatory submissions, manuscripts, and direct communication with key customers.

  • Respond to regulatory queries in collaboration with other statistical colleagues.

Therapeutic Area and Systems Knowledge:

  • Understand relevant disease states to enhance customer focus and collaboration.

  • Ensure replication of tools and systems where applicable and stay informed of technology advances.

Regulatory Compliance:

  • Perform work in full compliance with assigned curriculum(s).

  • Follow applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.

Lilly is committed to ensuring equal opportunities and providing accommodations during the application process.

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