Reddy Anand

Detail-oriented Senior Statistical Programmer with 7+ years of experience in the pharmaceutical and clinical research industry across Vaccines and Oncology therapeutic areas (Phases I, II, III). Proven expertise in developing and validating CDISC-compliant SDTM and ADaM datasets, including ADSL, ADAE, ADRS, ADTTE, and ADEFFSUM. Skilled in producing safety and efficacy Tables, Listings, and Figures (TLFs), survival analyses (Kaplan-Meier, log-rank, Cox proportional hazards), binomial response-rate summaries, and FDA regulatory submission deliverables (Define.xml, Patient Profiles, ADRG).

Strong working knowledge of Pinnacle 21, ICH-GCP guidelines, and SAS Base/Macros/Stat for pharmaceutical reporting. Familiar with BIMO (Bioresearch Monitoring), ISS (Integrated Summary of Safety), and ISE (Integrated Summary of Effectiveness) regulatory submission concepts; basic knowledge of R programming.

Senior Statistical Programmer - IQVIA RDS India - Bangalore

(2026-03 - 2026-08)

• Working as Senior SAS Programmer with a primary focus on biomarker data standardization in the Oncology therapeutic area.
• Developed and validated the BK (Biomarker) SDTM domain and ADBK (Biomarker Analysis) ADaM dataset in compliance with CDISC standards.
• Programmed summary tables for biomarker distributions, change from baseline, and biomarker-outcome correlations to support oncology efficacy analyses.
• Derived complex biomarker variables and implemented mapping specifications for exploratory and confirmatory biomarker endpoints.

Senior Statistical Programmer - Syneos Health India Pvt Limited - Hyderabad

(2025-07 - 2026-03)

• Experience in working in the therapeutic area Oncology etc.
• Worked closely with statisticians to generate TLFs for tumor response, adverse events, and survival analyses.
• Implemented censoring rules and derived time-to-event variables using complex date logic.
• Generating PSUR DSUR reports as per the snapshot dates its tool based.

Senior Statistical Programmer - Ephicacy Lifescience Analytics - Bangalore

(2022-02 - 2025-07)

Develop and validate ADaM datasets and TLFs for Vaccine and Oncology studies, supporting safety, efficacy and regulatory submission deliverables per CDISC and ICH-GCP standards.

• Reviewed study documents (annotated CRF, Protocol, SAP, TLF mock shells) to interpret analysis requirements and translate them into programming specifications.
• Developed and validated ADaM analysis datasets including ADSL, ADAE, ADLB, ADVS, ADRS (Tumor Response), ADTTE (Time-to-Event) and ADEFFSUM (Efficacy Summary), following CDISC ADaMIG v1.1 conventions and study-specific specifications.
• Generated and QC'd Safety tables (Adverse Events, Serious AEs, Treatment-Emergent AEs, Lab shifts, Vital Signs) and Efficacy tables (ORR, DCR, Best Overall Response, Duration of Response) using PROC FREQ, PROC MEANS and PROC REPORT.
• Produced time-to-event efficacy outputs (Overall Survival, Progression-Free Survival, Time to Progression) using PROC LIFETEST for Kaplan-Meier estimates, life-table summaries, median survival with 95% CI, and log-rank p-values.
• Derived Hazard Ratio tables comparing treatment arms using PROC PHREG (Cox proportional hazards model) with stratification factors per the SAP, including HR estimates, 95% confidence intervals, and Wald p-values.
• Generated binomial distribution outputs for response-rate analyses (ORR / CR / PR per RECIST 1.1) using PROC FREQ with the BINOMIAL option to obtain exact (Clopper-Pearson) and Wald 95% confidence intervals; computed between-arm comparisons using the Cochran-Mantel-Haenszel (CMH) test.
• Built and maintained reusable SAS macros for repetitive TLF programming (descriptive statistics, two-arm comparisons, survival displays) and debugged existing macros for new study requirements.
• Mapped raw EDC data to CDISC SDTM-compliant datasets and validated SDTM domains using Pinnacle 21 Community / Enterprise; reviewed and dispositioned compliance issues.
• Prepared and validated Define.xml, generated Patient Narratives, and supported the Analysis Data Reviewer's Guide (ADRG) for FDA regulatory submission packages.
• Performed independent QC via double programming and PROC COMPARE; documented validation findings and resolved discrepancies with the lead programmer and biostatistician.
• Recognized with two EMMES Spot Awards (2023, 2025) for high-quality on-time delivery and contribution to study milestones.

SDTM Programmer - Tata Consultancy Services. - Mumbai

(2021-02 - 2022-01)

Generated SDTM datasets and analysis outputs in line with client requirements and regulatory standards.

• Compared newly loaded source data against previous data loads to identify changes, inconsistencies and downstream programming impacts.
• Implemented SAS programs by reviewing the protocol and SDTM mapping specifications, then generating production datasets from source data.
• Validated SDTM datasets through independent double programming and PROC COMPARE against production outputs to confirm conformance with SDTM IG.
• Generated Pinnacle 21 reports and dispositioned issues based on severity categorization (Reject / Error / Warning / Notice).
• Participated in TEST and PROD data verification activities and maintained validation documentation for audit readiness.
• Supported development of analysis-ready datasets feeding into safety and efficacy summary tables.

Jr Study Programmer - Makro Care Clinical Research Pvt Ltd - Hyderabad

(2018-03 - 2020-03)

Generated SDTM datasets and analysis outputs in line with client requirements and regulatory standards.

• Compared newly loaded source data against previous data loads to identify changes, inconsistencies and downstream programming impacts.
• Implemented SAS programs by reviewing the protocol and SDTM mapping specifications, then generating production datasets from source data.
• Validated SDTM datasets through independent double programming and PROC COMPARE against production outputs to confirm conformance with SDTM IG.
• Generated Pinnacle 21 reports and dispositioned issues based on severity categorization (Reject / Error / Warning / Notice).
• Participated in TEST and PROD data verification activities and maintained validation documentation for audit readiness.
• Supported development of analysis-ready datasets feeding into safety and efficacy summary tables.

Bachelor of Pharmacy - JNTU Hyderabad (2016)