Chris Whitaker

Results-driven Statistical Programmer with seasoned years of experience in the biopharmaceutical and CRO industry, specializing in clinical trial data analysis and regulatory submissions. Expertise in transforming raw clinical data into CDISC-compliant SDTM and ADaM datasets and generating complex tables, listings, and figures for safety and efficacy endpoints. Highly skilled in SAS programming, Define.xml generation, and SDTM-annotated CRF development.

Adept at collaborating with biostatisticians and data management teams to ensure data integrity, resolve discrepancies, and deliver audit-ready outputs that meet industry standards.

Statistical Programmer II at SYNEOS HEALTH (2022-08 – 2026-08)

• Maintained comprehensive project tracking and specification accuracy by updating and managing all Statistical Programming project documentation.
• Delivered validated and production-ready ADaM datasets and Tables, Listings, and Figures (TLFs) by supporting the Lead Statistical Programmer in program development.
• Generated complex safety and efficacy TLFs by utilizing advanced statistical procedures, including PROC LIFETEST, GLM, ANOVA, FREQ, and MI.
• Safeguarded data integrity by identifying, logging, and reporting data discrepancies as they were discovered during programming.
• Created comprehensive analysis-ready datasets by integrating third-party data sources, including lab results, vital signs, and medical coding data.
• Expanded technical capabilities by completing employer-provided R training and applying ADMIRAL, TPLYR, RTABLES, MMRM, and SURVIVAL libraries to statistical programming tasks.

Statistical Programmer II at IQVIA INC. (2021-11 – 2022-08)

• Produced accurate TLF outputs by creating and updating analysis datasets and leveraging company proprietary software.
• Unified disparate clinical data by programming the integration of databases from multiple studies and external sources.
• Ensured high data quality by promptly identifying and reporting data issues during programming and review phases.
• Maintained project alignment and compliance by updating and managing programming specifications and tracking logs.

Statistical Programmer II at ICON GPHS (2021-02 – 2021-11)

• Delivered error-free safety and efficacy outputs by creating and rigorously validating analysis datasets and TLFs.
• Improved programming efficiency and reusability by creating, documenting, and validating macros at the table, listing, and figure level.
• Guided accurate data structuring by developing detailed safety specifications for analysis datasets, tables, and listings.
• Accelerated project timelines by proactively communicating and collaborating effectively with biostatisticians and data management teams.
• Ensured adherence to CDISC standards by creating and updating ADaM safety specifications.

Statistical Programmer at CTI CLINICAL TRIALS (2018-06 – 2021-02)

• Enabled accurate Statistical Analysis Plan (SAP) execution by developing SDTM dataset specifications and leading the creation of ADaM dataset specifications and TLF shells.
• Ensured accurate data capture and mapping by reviewing and developing SDTM-annotated Case Report Forms (CRFs).
• Delivered compliant SAS dataset deliverables by programming SDTM and ADaM structures exactly to project specifications.
• Facilitated successful regulatory submissions by reviewing Open CDISC findings and generating comprehensive Reviewers Guides and Define.xml files.
• Improved analytical frameworks by reviewing SAPs and TLF shells and providing actionable feedback to statisticians.
• Produced final clinical study outputs by programming Tables, Listings, and Figures in strict accordance with mock TLF shells.

Category Analyst/Developer at IMPACT SALES AND MARKETING (2015-04 – 2018-06)

• Automated complex data extraction from web-based sources by developing SQL queries and directing a small development team.
• Enhanced system accessibility and scalability by successfully migrating data from local sources to a cloud-based server.
• Improved data accessibility for stakeholders by independently building a reporting system that generated and stored readily available monthly reports.
• Empowered business managers and clients to make informed decisions by supplying critical data insights and opportunities during category reviews.
• Increased operational efficiency by developing new reports and implementing automated generation processes.

Programmer/Analyst at THE STEVENSON COMPANY

B.S. in Applied Math - Concentration in Statistics – Northern Kentucky University