Clinical SAS Programmer with CDISC SDTM/ADaM Expertise
Resume:
RAJESH VALUSA
****************@*****.***
https://www.linkedin.com/in/rajesh-valusa-b44557262/ Professional Summary:
• Clinical SAS Programmer with 6.2 years of experience in pharmaceutical and CRO environments.
• Proficient in generating CDISC-compliant SDTM and ADaM datasets for regulatory submissions.
• Extensive experience in programming Tables, Listings, and Figures (TLFs) as per SAP requirements.
• Well-versed in clinical study protocols, CRFs, and metadata-driven programming.
• Skilled in validating SDTM datasets using Pinnacle 21 and ensuring compliance with FDA submission standards.
• Strong knowledge of CDISC standards and hands-on experience with mapping raw data to SDTM/ADaM.
• Proficient in SAS programming (BASE, MACRO, SQL) and tools such as SAS Enterprise Guide and SAS Studio.
• Adept at creating and reviewing programming specifications for datasets and TLFs.
• Worked across therapeutic areas such as Oncology and Infectious diseases across Phases I–III.
• Collaborated effectively with cross-functional teams including Biostatisticians, Data Managers, and Clinical Teams.
• Experience in conducting quality control checks and ensuring audit readiness for statistical deliverables.
• Skilled in handling data from multiple sources including Teradata, Oracle, DB2, and SQL Server.
• Excellent at documentation and maintaining version control and traceability in deliverables.
• Familiar with submission processes, eCTD standards, and supporting regulatory filing requirements.
• Strong communicator with the ability to provide technical guidance and mentorship to junior team members.
• Proven ability to deliver high-quality results under tight timelines in a fast-paced environment. Technical Expertise:
• Programming Languages: SAS (BASE, MACRO, SQL), SQL
• Clinical Standards: CDISC SDTM, ADaM, TLFs, Pinnacle 21
• Tools: SAS Enterprise Guide, SAS Studio, SAS Management Console, SAS Data Integration Studio, SAS Web Report Studio, SAS Information Map Studio, SAS OLAP & EBI Server
• Databases: Teradata, DB2, Oracle, SQL Server
• Operating Systems: Windows XP, Windows 10
• Others: Good understanding of regulatory submission standards and validation tools Education:
• University of New haven - Business Analytics – Dec 2024
• Vaagdevi College of Engineering – Mechanical Engineering – Mar 2018 Professional Experience
Humana, TX, USA
Clinical SAS Programmer Jun 2023 – Till date
Responsibilities:
• Lead the end-to-end statistical programming activities for clinical trials from protocol review to database lock.
• Developed, validated, and reviewed CDISC SDTM and ADaM datasets per study timelines.
• Generated high-quality TLFs for interim and final clinical study reports using derived datasets.
• Reviewed statistical analysis plans and derived programming logic based on SAP requirements.
• Performed data validation using Pinnacle 21 and resolved issues to ensure submission readiness.
• Ensured adherence to CDISC and company-specific programming guidelines and standards.
• Participated in study startup and milestone planning meetings, providing technical inputs.
• Coordinated with global cross-functional teams for efficient data delivery and review.
• Provided oversight, technical support, and code reviews to junior SAS programmers.
• Contributed to audit preparation and maintained compliance documentation for studies.
• Managed version control for programs and datasets using internal tracking systems.
• Automated repetitive programming tasks using advanced SAS macros and reusable code.
• Supported creation and review of define.xml and reviewer’s guide for eCTD submissions.
• Analyzed raw clinical data to identify trends, inconsistencies, and missing information.
• Conducted root-cause analysis of data discrepancies during blinded and unblinded reviews.
• Developed custom reports and KPI summaries for clinical operations tracking.
• Collaborated with safety teams to integrate adverse event data into SDTM domains.
• Designed dynamic reporting templates to reduce manual effort across multiple studies.
• Integrated external lab data and device data sources into standardized reporting formats.
• Built validation plans and performed dry runs before formal QC cycles to detect early issues.
• Participated in eSubmission walkthroughs with regulatory teams to ensure readiness for filing.
• Automated generation of patient narratives for SAE cases using macro-driven processes.
• Interacted with EDC vendors to clarify raw data structure for accurate mapping to SDTM.
• Supported interim analysis programming for DSMB meetings with rapid turnaround needs.
• Ensured data integrity, traceability, and consistency between raw, SDTM, ADaM, and output datasets.
Environment: SAS/BASE, SAS/MACRO, SAS/ETS, SAS/CONNECT, SAS Business Intelligence, SAS Enterprise Guide, SAS Enterprise Miner, SAS Web Report Studio, SAS Data Integration Studio, SAS Information Map Studio, SAS Management Console, SAS OLAP & EBI Server, Teradata, DB2, ORACLE, SQL Server, Windows XP
Navit Software Solutions Pvt, Ltd, Hyderabad, India Clinical SAS Programmer Jun 2018 – Dec 2022
Responsibilities:
• Supported statistical programming for global clinical trials across various therapeutic areas.
• Mapped raw datasets to SDTM format following CDISC implementation guides and sponsor standards.
• Created ADaM datasets used for generating statistical outputs in compliance with SAP.
• Wrote SAS programs for TLFs related to safety and efficacy endpoints.
• Validated and QC'd datasets and outputs produced by peers and internal teams.
• Developed annotated CRFs and maintained metadata and programming specifications.
• Liaised with Data Management and Biostatistics teams for issue resolution and clarifications.
• Participated in programming strategy discussions and provided study-level technical support.
• Conducted internal code reviews and provided improvements to existing programs.
• Ensured datasets passed all Pinnacle 21 checks with no major validation errors.
• Delivered outputs for internal reviews, DSMBs, and regulatory submissions on time.
• Created interactive SAS reports for non-technical users to explore trends in patient demographics.
• Standardized data derivation logic across studies to streamline documentation and reuse.
• Designed custom edit checks and discrepancy reports for early data cleaning efforts.
• Engaged in mock submission projects to familiarize with regulatory formatting and structure.
• Trained interns and junior team members on basic CDISC, SDTM, and SAS techniques.
• Wrote gap analysis reports comparing CRF data with raw dataset contents for QA purposes.
• Assisted with historical data analysis to support protocol amendments and study design changes.
• Implemented tracker programs to monitor incoming CRF pages and data entry progress.
• Supported submission of DSURs (Development Safety Update Reports) with compiled datasets.
• Maintained high coding standards with clear documentation and consistent formatting.
• Created utilities and reusable macros to streamline recurring programming tasks.
• Supported multiple concurrent studies while maintaining accuracy and efficiency.
• Provided input for SOPs and contributed to internal training on CDISC and SAS best practices. Environment: SAS/BASE, SAS/MACRO, SAS/ETS, SAS/CONNECT, SAS Business Intelligence, SAS Enterprise Guide, SAS Enterprise Miner, SAS Web Report Studio, SAS Data Integration Studio, SAS Information Map Studio, SAS Management Console, SAS OLAP & EBI Server, Teradata, DB2, ORACLE, SQL Server, Windows XP
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