Principal Analyst - Statistical Programming

JOB DESCRIPTIONJob title : Principal Analyst - Statistical ProgrammingReports to : Operation Head – India BUJob purposeThe Principal Analyst – Statistical Programming is responsible for leading end-to-end clinical trial programming activities including SDTM, ADaM, and TFL development in compliance with CDISC, FDA, and sponsor standards. The role requires expertise in SAS programming, regulatory submissions, data traceability, quality control, metadata preparation, and cross-functional coordination to support successful clinical study deliveries.The candidate will independently manage programming activities, mentor junior programmers, ensure regulatory compliance, and deliver high-quality submission-ready datasets and outputs within timelines.Duties and responsibilitiesSDTM Programming & ValidationPerform CRF annotation and maintain complete traceability from raw data to SDTM datasets as per CDISC SDTMIG standards.Develop and validate SDTM domains including DM, AE, CM, EX, VS, LB, MH, DS, SV, SE, OE, PR, PE, TS, TE, TA, TV, TI, QS and protocol-specific domains.Review raw clinical data, identify inconsistencies, and map raw variables to SDTM specifications.Develop derivation logic for study day, epoch, visit variables, timing variables, baseline flags, and other SDTM derivations.Create production and independent QC programs for SDTM datasets and perform validation using PROC COMPARE and additional QC techniques.Validate SDTM datasets using Pinnacle 21 Enterprise and resolve Errors, Warnings, and Notices with appropriate justifications.Prepare and validate Define.xml metadata including dataset metadata, variable metadata, controlled terminology, computational methods, and value-level metadata.Prepare Study Data Reviewer’s Guide (SDRG) with mapping decisions, reviewer guidance, and validation explanations.Maintain clean SAS logs, proper documentation, and audit-ready deliverables.Ensure all SDTM deliverables comply with CDISC, FDA, SOPs, and sponsor submission standards.2 .ADaM Programming & Analysis Dataset DevelopmentDevelop and validate ADaM datasets including ADSL, ADAE, ADLB, ADVS, ADCM, ADOE, and other efficacy and safety analysis datasets.Implement complex derivations including treatment-emergent flags, baseline flags, analysis visit windows, change-from-baseline, imputation logic, censoring rules, endpoint derivations, and population flags.Ensure complete traceability from SDTM to ADaM datasets and TFL outputs.Develop production and independent QC programs and perform double programming validation using PROC COMPARE and detailed review procedures.Validate ADaM datasets using Pinnacle 21 Enterprise and resolve compliance findings.Prepare ADRG and Define.xml documentation including derivation methodologies, computational methods, and reviewer guidance.Ensure all ADaM deliverables align with protocol, SAP, mock shells, sponsor standards, and regulatory requirements.Maintain clean SAS logs, programming documentation, and version-controlled deliverables.3 . TFL Programming & Statistical OutputsGenerate Tables, Listings, and Figures (TFLs) as per SAP, mock shells, and sponsor specifications.Develop production and QC programs for all TFL outputs and validate outputs using PROC COMPARE and statistical review procedures.Validate counts, percentages, summary statistics, p-values, confidence intervals, and derived statistical outputs.Develop high-quality graphical outputs including survival plots, box plots, trend graphs, and bar charts.Ensure outputs meet formatting and presentation standards including titles, footnotes, pagination, decimal alignment, and layout consistency.Prepare submission-ready outputs in RTF, PDF, Excel, and sponsor-specific formats.Perform comprehensive output review, issue tracking, discrepancy resolution, and documentation management.4 . Regulatory Compliance & Cross-Functional CoordinationSupport CSR preparation and regulatory submission activities with validated datasets, TFLs, and documentation.Coordinate with Biostatistics, Clinical, Data Management, Regulatory, and cross-functional teams to meet study timelines.Maintain audit-ready documentation, version control, and compliance with CDISC standards, SOPs, FDA requirements, and sponsor expectations.Ensure overall quality, reproducibility, accuracy, and regulatory compliance across all programming deliverables.Qualifications and ExperienceMSc in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field12 + years of related experience in SAS programming with clinical trial data in the Pharmaceutical & Biotech industry.SAS, (Base, Stat, Macro, graph); SAS certificates a plusStrong 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, reviewer’s guides, aCRFs) and Pinnacle21 validation.Skills & CompetenciesAbility to produce high-quality Tables, Listings, and Figures (TLFs) based on Statistical Analysis Plans(SAPs).Experience with Real-World Data (RWD), PK/PD calculations, and statistical modeling.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.Strong 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.Working conditionsThis positiono perates in an office setting,in person.Job may additionally require incumbent to be available outside of these hours to handle priority business needs.Direct reportsN/A

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