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Principal/ Statistical Programmer

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: Principal/Statistical Programmer
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full Time, Regular
Job ID: R-64916

Job Description:

The Principal/Statistical Programmer will support programming activities for data analysis of clinical trials, including creating standard datasets (SDTM), analysis datasets (ADaM), and generating reports like Tables, Listings, and Graphs. The role involves collaborating with statistical colleagues and study personnel, assisting in statistical analysis plan creation, and communicating results effectively.

Key Responsibilities:

  1. Data Analysis Support:

    • Support programming activities related to the analysis of clinical trial data.
    • Create standard datasets (SDTM) and analysis datasets (ADaM).
    • Generate Tables, Listings, and Graphs for clinical trial reports.
    • Assist with documentation tasks, such as Define, RGs, and CRT packages.
  2. Collaboration:

    • Collaborate with statistical colleagues and study personnel to provide input to statistical analysis plans.
    • Assist in selecting statistical methods for data analysis and conduct the analysis once the reporting database is created.
  3. Data Quality Assurance:

    • Work with data management to plan and implement data quality assurance plans.
  4. Methodology & Technology:

    • Maintain proficiency in SAS programming and statistical methodologies.
    • Stay updated on new statistical methods and technologies.
    • Justify methods selected and implement analysis plans.
    • Conduct peer reviews of work products from statistical colleagues.
  5. Results Communication:

    • Collaborate with statistical colleagues to write reports and communicate study results.
    • Assist in regulatory submissions and manuscripts.
    • Communicate with key customers and respond to regulatory queries.
  6. Therapeutic Area Knowledge:

    • Understand relevant disease states to enhance customer focus and collaboration.
    • Stay informed of technology advances and ensure the replication of tools and systems where applicable.
  7. Regulatory Compliance:

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

Qualifications:

  • Strong knowledge and experience in statistical programming (SAS).
  • Experience with creating SDTM and ADaM datasets.
  • Expertise in statistical methodology and data analysis.
  • Ability to collaborate with cross-functional teams and communicate results effectively.
  • Ability to stay updated on regulatory requirements and industry trends.

Additional Information:

  • Lilly is committed to providing equal opportunities for individuals with disabilities to engage in the workforce. If accommodations are needed during the application process, please use the accommodation request form.

Equal Opportunity Statement:

Lilly is an equal opportunity employer and 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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