Job Title:
Principal Statistical Programmer
Location:
Bangalore, Karnataka, India
Company:
Lilly
Job Description:
The Principal Statistical Programmer will support all programming activities required for the data analysis of clinical trials, create standard datasets (SDTM) and analysis datasets (ADaM), and generate reports including tables, listings, and graphs. The role involves collaborating with statistical colleagues to provide input to statistical analysis plans, assisting in data analysis, and ensuring high-quality work in compliance with regulatory standards.
Key Responsibilities:
Programming and Data Analysis:
Create SDTM and ADaM datasets for clinical trials.
Generate reports such as Tables, Listings, and Graphs.
Collaborate with study personnel to develop statistical analysis plans.
Select statistical methods, author sections of the data analysis plan, and conduct analysis.
Collaborate with data management in implementing data quality assurance plans.
Documentation and Reporting:
Assist with documentation tasks like Define, RGs, and CRT packages.
Write reports and communicate results for regulatory submissions, manuscripts, and one-on-one interactions with key stakeholders.
Assist or respond to regulatory queries in collaboration with statistical colleagues.
Methodology and Process:
Maintain proficiency in SAS programming and statistical methodology.
Ensure proper justification of statistical methods selected for analysis.
Review work products from statistical colleagues and conduct peer reviews.
Regulatory Compliance:
Perform work in compliance with corporate, medical, and departmental policies and training requirements.
Required Qualifications:
Education:
Bachelor’s degree or equivalent in a related field (e.g., Statistics, Mathematics, Life Sciences).
Experience:
Proven experience in statistical programming, particularly in clinical research or a similar field.
Experience with SAS programming and statistical methodology.
Skills:
Strong communication skills for reporting and collaborating with cross-functional teams.
Familiarity with regulatory requirements and CDISC standards.
Ability to collaborate and provide input to study teams effectively.
Preferred Skills:
Advanced knowledge of SAS programming and clinical trial analysis.
Experience in handling regulatory submissions.
Strong analytical skills and attention to detail.
Benefits:
Competitive salary and benefits.
Opportunities for career growth and professional development.
Inclusive and collaborative work environment.
Gujarat :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Siliguri |Illinois :
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Japan | Saitama |Tokyo :
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