Statistical Programmer II
Company: ICON plc
Location: Bangalore, India
Work Mode: Office or Home (Hybrid/Remote)
Department: Biostatistics & Statistical Programming
Employment Type: Full-Time
Experience: 3–5 years of experience in Statistical Programming within the clinical research industry, with expertise in SAS, R, or Python, clinical trial data analysis, and regulatory reporting.
Salary Package: ₹10–16 LPA (Approx., based on current market standards; final compensation depends on candidate experience, programming expertise, and clinical trial exposure.)
Role Overview
The Statistical Programmer II is responsible for developing, validating, and maintaining statistical programs that support clinical trial analysis, reporting, and regulatory submissions. The role works closely with biostatisticians and cross-functional teams to deliver high-quality statistical outputs while ensuring compliance with industry regulations and data standards.
Key Responsibilities
Statistical Programming
Develop, validate, and maintain complex statistical programs using SAS, R, Python, or similar programming languages.
Perform data manipulation, analysis, and reporting for clinical trials.
Create and validate derived datasets for statistical analyses.
Ensure programming deliverables are completed accurately and within project timelines.
Clinical Trial Data Analysis
Collaborate with biostatisticians to interpret study requirements and statistical methodologies.
Implement statistical analyses based on approved Statistical Analysis Plans (SAPs).
Generate Tables, Listings, and Figures (TLFs) to support clinical study reporting.
Review statistical outputs to ensure accuracy and consistency.
Regulatory Compliance
Prepare and review:
Statistical Analysis Plans (SAPs)
Programming specifications
Derived datasets
Ensure compliance with:
ICH-GCP Guidelines
Regulatory requirements
Company SOPs
Industry standards
Maintain data integrity throughout the programming lifecycle.
Cross-Functional Collaboration
Work closely with Biostatistics, Clinical Data Management, Clinical Operations, and Medical Writing teams.
Participate in project discussions and provide statistical programming expertise.
Support regulatory submissions through accurate programming deliverables.
Communicate complex statistical concepts effectively to both technical and non-technical stakeholders.
Team Support & Mentoring
Mentor junior Statistical Programmers.
Provide guidance on programming techniques, validation practices, and industry best practices.
Support knowledge sharing and continuous improvement initiatives within the programming team.
Contribute to process optimization and quality enhancement activities.
Educational Qualification
Bachelor's degree in:
Statistics
Computer Science
Mathematics
Data Science
Or another related discipline
Required Experience
3–5 years of Statistical Programming experience in the Clinical Research or CRO industry.
Strong experience with clinical trial data analysis and statistical reporting.
Hands-on experience with SAS, R, or Python programming.
Experience working with clinical data management systems.
Good understanding of clinical trial processes and statistical methodologies.
Technical Skills
Proficiency in:
SAS
R
Python
Experience creating:
Derived datasets
Tables, Listings & Figures (TLFs)
Statistical programming deliverables
Knowledge of Statistical Analysis Plans (SAPs).
Understanding of CDISC standards (SDTM/ADaM) is preferred.
Strong knowledge of ICH-GCP guidelines and regulatory requirements.
Proficiency in Microsoft Office applications.
Key Competencies
Strong analytical and problem-solving skills.
Excellent programming and validation abilities.
High attention to detail and data accuracy.
Strong communication and collaboration skills.
Ability to work independently and manage multiple projects.
Effective mentoring and knowledge-sharing capabilities.
Commitment to quality, compliance, and timely project delivery.
Strong organizational and time management skills.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Istanbul | Turkey |Norway :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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