Senior Statistical Programmer – Clinical Reporting & CDISC
Location: [Not Specified]
Experience Required: 10+ Years
Job Type: Full-Time
Job Overview:
We are currently seeking an experienced Senior Statistical Programmer Analyst I (SR SPA I) to join our high-performance programming team. This is a critical role supporting statistical programming activities for regulatory submissions, statistical reporting, and clinical publications. You will work independently to lead programming efforts and interface with both client and internal cross-functional teams.
Key Responsibilities:
Statistical Programming & Data Management:
Independently develop and validate SAS code to support generation of analysis datasets (ADaM), statistical tables, listings, and figures (TLFs).
Perform SAS-based SDTM and ADaM mapping, data transformation, and delivery of submission-ready datasets.
Generate statistical outputs for Clinical Study Reports (CSRs) including CTRs, ISS, ISE, and other safety updates or publication needs.
Provide programming support for regulatory submissions, publications, and safety updates.
Technical Expertise:
Develop SAS applications and macros to streamline programming processes.
Validate programming deliverables to ensure accuracy and compliance with CDISC standards and client specifications.
Perform migrations, verifications, and troubleshoot programming issues across platforms.
Collaboration & Project Support:
Interface with Data Managers, Biostatisticians, Clinical teams, and external clients to understand project needs and ensure alignment.
Take ownership of deliverables, timelines, and act as subject matter expert (SME) in one or more key domains:
CDISC (SDTM/ADaM)
define.xml creation
Tables and graphical outputs
Pharmacokinetics / Pharmacodynamics (PK/PD)
Project Management and regulatory submissions
Desirable Skills and Experience:
10+ years of experience in statistical programming within the pharmaceutical or CRO industry.
Strong knowledge and hands-on experience with SAS/Base, SAS/Macro, SAS/STAT.
Deep familiarity with CDISC standards, especially SDTM and ADaM.
Proficient in SAS programming across multiple platforms (Windows, UNIX).
Strong analytical background; statistics knowledge preferred.
Excellent problem-solving, communication, and documentation skills.
Ability to work independently while managing timelines and deliverables across multiple projects.
Estimated Salary: ₹20 – ₹32 LPA
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