Statistical Analysis for Clinical Trials & Medical Research
-
0 sales
- 43 views
- Save
0 /5.0
User reviewI provide full statistical analysis support for clinical trials, medical research, and healthcare studies. With 9+ years of experience and recent focus on FDA/EMA-regulated trials, I deliver analysis that is compliant, reproducible, and publication-ready.
My services include:
- Analysis of primary, secondary, and exploratory endpoints
- Time-to-event modelling (Kaplan–Meier, Cox regression, Fine–Gray competing risks)
- Longitudinal and repeated measures (MMRM, GLMM, GEE)
- Subgroup and sensitivity analyses (estimands per ICH E9(R1))
- Interim and multiplicity-adjusted analyses
- Generation of Tables, Figures, and Listings (TFLs) for CSRs
- Support for peer-reviewed journal publications
Software Expertise
SAS (PROC MIXED, GLIMMIX, PHREG, CDISC ADaM/SDTM outputs), R (tidyverse, survival, lme4, metafor, riskRegression), and Stata/SPSS for applied health data.
Send me your study details, and I will ensure robust, regulator-ready statistical outputs that strengthen your trial results.
Fequently asked questions
1. How does the process start?
First, share your study details, research questions, or protocol. I will review the requirements and propose the most suitable statistical approach before analysis begins.
2. How do you ensure data privacy?
All datasets are handled under strict confidentiality. Files are stored securely, never shared with third parties, and can be deleted after project completion. NDAs can be signed if needed.
3. Which types of studies do you analyse?
I analyse data from randomized controlled trials, cohort and prospective studies, longitudinal and repeated measures designs, observational and registry datasets, and healthcare or real-world evidence studies.
4. Which software do you use?
I mainly use SAS and R for advanced analysis. I also work with Stata, SPSS, PASS, and East depending on study requirements.
5. Do you follow regulatory or reporting standards?
Yes, analyses are aligned with ICH E9(R1), CONSORT, GCP, and CDISC standards when applicable, ensuring compliance for regulatory submissions and peer-reviewed publications.
6. Can you help with survival or time-to-event outcomes?
Yes, I perform Kaplan–Meier analysis, Cox regression, Fine–Gray competing risks, and recurrent event models for time-to-event and survival outcomes.
7. Do you handle missing data?
Yes, I use multiple imputation, mixed models, and sensitivity analyses, depending on study design and data structure, in line with ICH E9(R1) recommendations.
8. Can you provide publication-ready outputs?
Yes, I deliver results as structured tables, figures, and listings (TFLs), suitable for journal submission, CSRs, or internal reports.
9. What if I am not sure which analysis I need?
You can contact me with your research question or dataset. I will recommend the most suitable statistical approach and explain why it fits your study.
10. Do you also support interpretation and writing?
Yes, I can provide written statistical methods and results sections that are ready for inclusion in manuscripts, reports, or submissions.
