Job Title: Statistical Programmer II
Location: Remote (India)
Company: ICON Strategic Solutions
Job Summary:
ICON is hiring a Statistical Programmer II to join its global clinical research team. This remote opportunity is ideal for professionals with 4+ years of experience in statistical programming using SAS in the context of clinical trials. The role involves creation and QC of ADaM datasets, TLFs, and regulatory submission support using CDISC standards. Be part of an organization that leverages healthcare intelligence to drive meaningful impact in drug development.
Key Responsibilities:
Develop ADaM datasets following current CDISC ADaM standards
Generate Tables, Listings, and Figures per sponsor specifications
Support development of subject narratives using pre-defined templates
Program ancillary data streams (e.g., ClinTrials.gov, EudraCT, BIMO reports)
Perform QC of all programmed outputs
Document and maintain detailed specifications
Create and validate electronic submission packages (FDA, EMEA)
Support data integration across standalone and multi-study submissions
Required Skills & Qualifications:
Minimum 4+ years of experience in statistical programming for clinical trials
Proficiency in SAS Base and Macro programming
Strong understanding of clinical data including safety, efficacy, PK/PD
Familiarity with CDISC ADaM, SDTM, Controlled Terminologies
Experience with ADaM metadata, SAS code, and TAUG is a plus
Working knowledge of regulatory submission requirements
Perks & Benefits:
Competitive salary package
Multiple annual leave entitlements
Health insurance plans for you and your family
Retirement planning benefits
Life assurance coverage
Global Employee Assistance Programme
Country-specific perks (e.g., gym discounts, health assessments, travel passes)
Company Description:
ICON plc is a global leader in clinical research and healthcare intelligence. With a commitment to quality, diversity, and innovation, ICON supports sponsors in delivering impactful therapies. The company fosters an inclusive culture, where talent and performance are nurtured across all roles in the life sciences domain.
Work Mode:
Remote – Work from anywhere in India
Call to Action:
Ready to contribute to high-impact clinical research and grow your programming career? Apply now to become a part of ICON's award-winning global team.
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