Senior Statistical Programming Analyst (Hyderabad)

Ocugen India; Hyderabad; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Ocugen India is seeking a Principal Statistical Programmer to lead SAS programming, CDISC SDTM/ADaM data mapping, and validation for clinical trials. You will ensure data integrity and regulatory readiness across reports and submissions.

Collaborating with biostatistics, data management, and clinical teams, you will produce TLFS, support CSRs, and mentor junior programmers while upholding quality and compliance standards.

Qualifications

• Master's in Statistics, Mathematics, CS, Life Sciences or related field.
• 12–15 years as a statistical programmer in clinical research or pharma.
• Advanced SAS programming skills (Base SAS, SAS/STAT, SAS/GRAPH, SAS Macro).
• Strong CDISC SDTM/ADaM knowledge, data mapping, and SDTM/ADaM datasets.
• CDISC documentation (define.xml, reviewers guides, aCRFs) and Pinnacle21 validation.

Responsibilities

• Develop and maintain SAS programs for data processing, analysis, and reporting.
• Map clinical trial data to CDISC standards ensuring regulatory compliance.
• Create and maintain analysis datasets per CDISC guidelines.
• Perform data validation and quality checks to ensure integrity.
• Produce Tables, Listings, and Figures (TLFs) from SAPs.
• Collaborate with biostatistics, data management, and clinical teams.
• Support regulatory submissions including CSRs and safety listings.
• Mentor junior programmers and provide technical guidance.
• Maintain CDISC documentation and Pinnacle21 validation.

Skills

SAS programming

CDISC SDTM/ADaM

TLFs creation

Pinnacle21 validation

R/Python for analysis

Data mapping

Clinical data management collaboration

Data validation

Documentation & compliance

Education

Master's degree in Statistics or related field

Tools

Pinnacle21

SAS (Base, STAT, GRAPH, Macro)

define.xml validation

Job description

Job title: Principal Statistical Programmer

Reports to : VP Operations

Job Purpose :

To lead the programming, validation, and delivery of high-quality statistical outputs for clinical trials by applying advanced SAS programming and CDISC standards, ensuring data integrity, regulatory compliance, and timely support of statistical analyses, clinical study reports, and regulatory submissions through close collaboration with biostatistics, data management, and clinical teams.

Duties and responsibilities :

Programming & Data Management :

• Develop and maintain SAS programs for clinical trial data processing, analysis, and reporting.
• Map clinical trial data to CDISC standards (SDTM and ADaM) ensuring compliance with regulatory requirements.
• Create and maintain analysis datasets following CDISC implementation guidelines.
• Perform data validation and quality control checks to ensure data integrity.
• Expertise as Clinical SAS programmer: SAS programming language and software within the context of clinical research and healthcare, particularly in the pharmaceutical and biotechnology industries.
• Managing, analyzing, and reporting clinical trial data, ensuring accuracy, efficiency, and regulatory compliance.
• Data Management: SAS excels at handling large and complex datasets from various sources, including EDC systems and laboratory databases.
• Data Cleaning and Transformation: to facilitate identifying and resolving data discrepancies, transforming variables, and preparing data for analysis.
• Statistical Analysis: wide range of statistical procedures for analyzing clinical trial data, including descriptive statistics, regression analysis, survival analysis, and analysis of variance (ANOVA).
• Safety Reporting: generates safety reports and listings to monitor adverse events and safety data during the trial.
• SDTM (Standard Data Tabulation Model) and ADaM (Analysis Data Model) Implementation supports the conversion of clinical trial data into standardized formats for regulatory submissions.
• Report Generation prepares clinical trial reports, including summaries of safety and efficacy, clinical study reports (CSRs), and other regulatory documents.

Documentation & Compliance:

• Generate and maintain CDISC documentation including define. Xml files, reviewer's guides, and annotated case report forms (aCRF) is mandatory.
• Conduct Pinnacle21 validation checks and resolve any compliance issues.
• Ensure all deliverables meet regulatory submission standards (FDA, EMA, etc.).
• Maintain comprehensive programming documentation and version control.

Statistical Analysis & Reporting:

• Produce Tables, Listings, and Figures (TLFs) based on Statistical Analysis Plans (SAP).
• Collaborate with biostatisticians to implement complex statistical analyses.
• Support clinical study reports and regulatory submissions.
• Perform ad-hoc analyses as requested by clinical teams.

Cross-functional Collaboration:

• Work closely with clinical data management, biostatistics, and regulatory affairs teams.
• Participate in project meetings and provide technical expertise.
• Support timeline planning and deliverable tracking.
• Mentor junior programmers and provide technical guidance.

Qualifications and Experience

• Masters in Statistics, Mathematics, Computer Science, Life Sciences, or a related field.
• 12 to 15 years of experience as a statistical programmer in clinical research or pharmaceutical industry.
• Advanced SAS programming skills (Base SAS, SAS/STAT, SAS/GRAPH, SAS Macro).
• Strong understanding of clinical trial design, endpoints, and regulatory requirements.
• Proven expertise in CDISC standards (SDTM, ADaM), data mapping, and creation of compliant analysis datasets.
• Hands-on experience with CDISC documentation (define. Xml, reviewers guides, aCRFs) and Pinnacle21 validation.
• Ability to produce high-quality Tables, Listings, and Figures (TLFs) based on Statistical Analysis Plans(SAPs).

Skills & Competencies

• Experience with Real-World Data (RWD), PK/PD calculations, and statistical modelling.
• Proficiency in R, Python, or other statistical software for analysis and visualization.
• Knowledge of therapeutic areas, regulatory guidelines, and cloud-based platforms.
• Familiarity with version control systems and advanced data management techniques.
• Excellent written and verbal communication in English.
• Solid analytical and problem-solving skills with meticulous attention to detail.
• Effective collaboration and interpersonal skills for cross-functional teamwork.
• Adaptable, quick learner, with strong organizational and multitasking abilities.
• Certification in SAS is mandatory.

Working conditions :

This position operates in an office setting, in person.

Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Direct Reporting

N/A .