OBJECTIVE

• Seeking a challenging Senior SAS Programmer position in a progressive organization that allows me to enhance my knowledge of statistics and technical skills.

SUMMARY

• Over 7 years of experience in SAS programming, data analysis, and statistics for clinical studies
• Contributing to data mapping, data modeling, clinical trial protocols, SAP, and mock shells
• Strong experience in creating, developing, implementing and validating Macros for clinical study output and complex data manipulations
• Proficient in Import, clean, merge, split, and manipulate clinical trial data to prepare it for statistical analysis and reporting using SAS program
• Highly skilled SAS programmer with extensive experience in phase I - III clinical trials across various therapeutic areas such as oncology, diabetes, neuroscience etc.
• Comprehensive knowledge of CDISC standards (SDTM and ADaM) and regulatory requirements, encompassing Demographics (DM), Adverse Events (AE), Physical Examination (PE), Tumor Results (TR), Medical History (MH), and efficacy-related data
• Proficient in statistical analysis using a wide range of SAS procedures including PROC ANOVA, PROC LIFETEST, PROC PHREG, PROC MEANS, PROC FREQ, PROC SORT, PROC UNIVERIATE, PROC TRANSPOSE PROC SQL.
• Well-versed in data management, validation, and transformation techniques
• Familiar with Sample Size Calculation, Power test, Principal component analysis, Experimental Design, etc.
• Experienced in creating and maintaining efficient SAS macros for process improvement and productivity
• Expert in generating outputs using SAS ODS in multiple formats (RTF, LISTING, EXCEL)
• Skilled in developing TLFs based on SAPs and CRFs, contributing to their creation and review.
• Rigorous QC (quality control) and validation processes for data accuracy and integrity
• Skilled in creating and managing Relational and Multidimensional DBMS using various file formats, including XLS, CSV, and SQL Server databases
• Proficient in R and Python for data visualization, normalization, standardization, and various data analysis techniques, including ANOVA, Logistic Regression Analysis, Factor Analysis, Discriminant Analysis, MANOVA, Principal Component Analysis, Multivariate Analysis, and multiple model fitting
• Strong communicator and effective collaborator within cross-functional teams.
• Provides statistical analysis support for ad-hoc requests, FDA inquiries, and regulatory submissions (ISS and ISE)
• Committed to continuous improvement and staying up-to-date with industry trends and best practices
• Proven track record in advancing clinical research through data-driven insights and innovative problem-solving

TECHNICAL SKILLS

• SAS /SQL SAS /MACRO
• SAS/STAT and SAS/ODS
• CDISC
• SDTM and ADaM
• R
• SOL Server
• Python

PROFESSIONAL EXPERIENCE

Senior SAS Programmer

Confidential

Responsibilities:

• Developed SAS programs for clinical trials data for phase I-III clinical trials.
• Developed and validated ADaM datasets (ADTTE, ADLB, ADAE, ADSL, ADVS) following CDISC standards for various therapeutic areas.
• Prepared data packages for FDA submissions, including Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
• Conducted data validation and quality control to ensure accuracy and integrity of clinical trial data.
• Created and maintained SAS macros for improved efficiency and standardization across projects.
• Performed statistical analysis using SAS procedures (PROC ANOVA, PROC LIFETEST, PROC PHREG, PROC MEANS, PROC FREQ, PROC SORT, PROC UNIVERIATE, PROC TRANSPOSE PROC SQL, PROC MERGE).
• Generated outputs in multiple formats (RTF, LISTING, EXCEL) using SAS ODS.
• Developed tables, listings, and figures (TLFs) based on Statistical Analysis Plans (SAPs) and Case Report Forms (CRFs).
• Contributed to the creation and review of SAPs and CRFs for alignment with study objectives and data requirements.
• Mapped and converted clinical trial data to SDTM format in compliance with CDISC guidelines such as DM, EX, CM, AE, SUPPAE, LB, VS, TU, TR, etc.
• Checked and validated CRO deliverables to ensure compliance with company requirements
• Participated in meetings with statisticians to discuss and resolve project issues
• Provided statistical analysis and SAS programming support for ad-hoc requests and FDA inquiries

Senior SAS Programmer

Confidential, Round Lake, IL

Responsibilities:

• Reviewed protocols, CRFs, SAPs, TFL shells, SOPs, data specifications, and CSRs to ensure accurate and consistent data analysis and reporting.
• Produced and validated ISS/ISE tables, listings, and figures for regulatory submissions.
• Performed validation on ADaM/ADS datasets and TLFs to ensure data integrity and compliance.
• Prepared data specifications for ADaM datasets and validated standard and custom SDTM domains.
• Developed CDISC/SDTM domains for phase II-III studies per mapping specifications and SDTMIGs.
• Worked on statistical modeling using various SAS procedures and provided quality control for ADaM datasets in CDISC structure (e.g., ADLB, ADAE, ADSL, ADVS).
• Developed, modified, and maintained SAS macros to improve programming efficiency.
• Implemented SAS programming for phase II and III clinical trials and drafted statistical analysis plans for phase I and II studies.
• Created SAS programs for editing, checking, and reviewing raw/derived data.
• Performed standard CDISC SDTM and ADaM dataset preparation for efficacy and safety analyses and provided new SDTM specifications for analysis datasets.
• Debugged and improved existing SAS macros using various debugging options

SAS Programmer

Confidential, Basking bridge, NJ

Responsibilities:

• Imported external data into SAS for processing and analysis
• Developed SAS programs to create Tables, Listings, and Figures (TFLs) for reporting purposes
• Exported datasets and generated reports based on established standards and
• Reviewed mapping specifications and CRFs to generate accurate and consistent datasets.
• Created SAS macros to improve efficiency and streamline processes
• Utilized various SAS procedures, including PROC FREQ, PROC SORT, PROC SQL, PROC FORMAT, and PROC REPORT, for data management and analysis.
• Expertly applied statistical procedures, such as PROC UNIVARIATE, and PROC LIFETEST, within SAPs to guide programmers in generating essential statistics.
• Proficient in developing CDISC/SDTM domains, such as DM, AE, LB, VS, etc., for Phase I-II studies in accordance with Mapping Specifications and SDTMIGs.
• Expertly generated summaries and graphs in accordance with SAPs and other specified requirements.