Senior/Principal Statistical Programmer

550 Eli Lilly Services India Pvt Ltd; Bengaluru; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Senior/Principal Statistical Programmer position at Lilly in Bengaluru. You will support the data analysis of clinical trials, create SDTM and ADaM datasets, and generate tables, listings and graphs for reporting.

Collaboration with statisticians and study personnel helps shape analysis plans and regulatory submissions. You will maintain SAS proficiency and apply evolving statistical methods, support defines and CRT packages, and contribute to regulatory communications with customers and

Qualifications

• Experience in SAS programming for clinical trial data analysis.
• Ability to create SDTM and ADaM datasets and reports.
• Experience supporting regulatory submissions and Define/CRT documents.

Responsibilities

• Support programming activities for the data analysis of the clinical trials and create standard datasets (SDTM) and analysis datasets (ADaM) and generate reports of the form Tables, Listings and Graphs are applicable.
• Support other documentation tasks such as Define, RGs and CRT packages as required for the reporting of clinical trials.
• Collaborate with other statistical colleagues and study personnel to provide input to statistical analysis plans.
• Assist in and/or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the data analysis plan, and conducting the actual analysis once a reporting database is created.
• Collaborate with data management in the planning and implementation of data quality assurance plans.
• Maintain proficiency with respect to SAS programming and statistical methodology and in applying new and varied methods.
• Effectively justify methods selected and implement previously outlined analysis plans.
• Conduct peer-review of work products from statistical colleagues.
• Effectively utilize current technologies and available tools for conducting the clinical trial analysis.
• Collaborate with other statistical colleagues to write reports and communicate results.
• Responsible for assisting in the communication of study results via regulatory submissions, and manuscripts, as well as for communicating one‑on‑one with key customers.
• Assist or respond to regulatory queries working in collaboration with other statistical colleagues.
• Understand relevant disease states in order to enhance the level of customer focus and collaboration.
• Ensure replication of tools and systems, where applicable and stay informed of technology advances.
• Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes and training.

Skills

SAS programming

Statistical analysis

Clinical trial data

Tools

SAS software

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Senior/Principal Statistical Programmer

About Lilly

At Lilly, everything we do starts with patients. We unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, our global team of over 50,000 employees work with urgency and purpose to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. We bring our best to this work because people depend on it. If you're driven by purpose and determined to make a meaningful difference for patients, we invite you to bring your skill and your commitment to Lilly.

Research Labs, Bengaluru

At Lilly in Bengaluru, the research function works directly alongside Lilly's global teams to advance the science behind tomorrow's medicines. Whether through product research and development, computational modelling, data-driven experimentation, or the intelligence that shapes Lilly's external innovation strategy, the work here contributes to the pipeline that will determine which life-changing medicines reach patients across the globe.

Job Description

Statistical Trial Analysis

• Support all programming activities required for the data analysis of the clinical trials and create standard datasets (SDTM) and analysis datasets (ADaM) and generate reports of the form Tables, Listings and Graphs are applicable.
• Support other documentation tasks such as Define, RGs and CRT packages as required for the reporting of clinical trials.
• Collaborate with other statistical colleagues and study personnel to provide input to statistical analysis plans.
• Assist in and/or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the data analysis plan, and conducting the actual analysis once a reporting database is created.
• Collaborate with data management in the planning and implementation of data quality assurance plans.
• Maintain proficiency with respect to SAS programming and statistical methodology and in applying new and varied methods.
• Effectively justify methods selected and implement previously outlined analysis plans.
• Conduct peer-review of work products from statistical colleagues.
• Effectively utilize current technologies and available tools for conducting the clinical trial analysis.

Communication of Results and Inferences

• Collaborate with other statistical colleagues to write reports and communicate results.
• Responsible for assisting in the communication of study results via regulatory submissions, and manuscripts, as well as for communicating one‑on‑one with key customers.
• Assist or respond to regulatory queries working in collaboration with other statistical colleagues.

Therapeutic Area and Systems Knowledge

• Understand relevant disease states in order to enhance the level of 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) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes and training.

At Lilly, caring is not only what we do for patients. It is how we work. We believe the people who dedicate themselves to making medicines better deserve an environment that makes their lives better too, one where they are supported, respected, and given the space to do their best work. This is not just a policy. It is who we are. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. 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.

#WeAreLilly

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly