Statistical Programming
I can provide expert statistical programming services to empower clinical research with robust, compliant, and actionable data analysis. My solutions ensure precision and regulatory adherence, driving success in your trials and studies. Partner with me for specialized expertise in:
Statistical Programming: Deliver high-quality, validated statistical programs for efficient data analysis and reporting, using tools like R and SAS to meet industry standards. Click to see an example of SAS and R programming.
Study Design and Protocol Development: Create scientifically rigorous study designs and protocols that align with clinical objectives and regulatory guidelines.
Sample Size Calculations & Randomization Schema: Conduct precise power and sample size calculations to optimize study feasibility and ensure statistical validity — R or PASS Software. Design and implement randomization plans to minimize bias and uphold the integrity of clinical trials. Click to see an example of a randomization scheme.
Statistical Analysis Plans (SAPs): Develop detailed SAPs that outline methodologies, endpoints, and analyses to ensure reproducible, transparent results. Click to see an example of Rmarkdown SAP.
Data Safety and Monitoring Board (DSMB) Support: Provide statistical expertise and interim analyses to support DSMBs and ensure trial safety and efficacy. Click to see an automated safety report.
Tables, Listings, and Figures (TLFs): Generate transparent, compliant, and publication-ready TLFs to present study findings effectively. Click to see an example of an automated mock TLFs.
CDISC Compliance: Ensure data adheres to CDISC standards (SDTM, ADaM) for seamless regulatory submissions and interoperability —experience with P21 Validator.
Clinical Study Reports (CSRs): Author comprehensive CSRs that integrate statistical results and clinical insights and meet regulatory and publication requirements.
My experience in statistics and programming delivers tailored, high-quality solutions to accelerate your research and ensure regulatory success. Contact me today to explore how I can support your clinical projects.