Senior Statistical Programmer

5+ years

Not Disclosed

Bangalore

10 Jan. 29, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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 Statistical Programmer
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full Time, Regular
Job Id: R-64916

About Lilly:

At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, we work to discover and bring life-changing medicines to those in need. Our employees are committed to improving the understanding and management of disease while giving back to the communities we serve.

Job Description:

As a Senior Statistical Programmer, you will support all programming activities required for the analysis of clinical trial data. You will be responsible for creating standard datasets (SDTM) and analysis datasets (ADaM), and generating reports in the form of Tables, Listings, and Graphs (TLGs) to support clinical trial reporting.

Key Responsibilities:

Programming and Data Analysis:
- Develop standard datasets (SDTM, ADaM) and analysis outputs such as Tables, Listings, and Graphs (TLGs) for clinical trial reports.
- Collaborate with statistical colleagues to provide input into statistical analysis plans.
- Select appropriate statistical methods for data analysis and author corresponding sections of the data analysis plan.
- Conduct analyses once the reporting database is created, ensuring consistency and accuracy of results.
Documentation and Regulatory Support:
- Assist with documentation tasks, including the creation of Define, RGs, and CRT packages.
- Collaborate with cross-functional teams to write reports and communicate results to regulatory bodies, and assist in regulatory submissions and responses to regulatory queries.
Collaboration and Communication:
- Work closely with data management and other teams to develop and implement data quality assurance plans.
- Collaborate with statistical colleagues to peer-review work products and ensure adherence to internal standards.
- Communicate study results to key stakeholders and regulatory authorities, as well as contributing to manuscripts.
Methodology and Technology:
- Maintain proficiency in SAS programming and statistical methodology, applying new methods and technologies to clinical trial analysis.
- Use current technologies and tools for clinical trial analysis and ensure that work complies with regulatory standards.
- Stay informed on the latest advancements in statistical techniques and programming technologies.
Compliance:
- Perform work in full compliance with corporate, medical, local, and departmental policies, procedures, and training programs.
- Ensure all work adheres to Lilly’s regulatory and quality standards.

Qualifications:

Educational Requirements:
- A Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or a related field.
Experience:
- A minimum of 5+ years of experience in statistical programming, preferably within the pharmaceutical or clinical research industry.
- Strong experience with SAS programming and a deep understanding of statistical methodologies used in clinical trials.
- Familiarity with SDTM, ADaM, and TLG creation.
Skills:
- Excellent analytical, problem-solving, and communication skills.
- Ability to collaborate effectively with cross-functional teams.
- Experience working with regulatory submissions and an understanding of regulatory requirements.
Desirable:
- Familiarity with other statistical programming languages or tools (e.g., R, Python) is a plus.
- Knowledge of therapeutic areas and clinical trial design.

Additional Information:

The position may involve limited travel (up to approximately 10%).
Lilly is committed to diversity and inclusion and encourages applications from all qualified individuals.

Equal Opportunity Employer:

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

Apply today to be a part of our team and help make life better for people around the world!

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Senior Statistical Programmer

Job Description

About Lilly:

Job Description:

Key Responsibilities:

Qualifications:

Additional Information:

Equal Opportunity Employer:

Apply today to be a part of our team and help make life better for people around the world!

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