Biostatistics
Zephyr Tech offers a wide variety of biostatistics services to support the analysis and reporting of clinical data. Our Biostatisticians have experience leading statistical analysis for a number of studies from Phases I to IV of clinical development, including Real World Evidence and Observational studies.
Our talented team of biostatisticians provide biostatistical consulting services for pre-clinical, clinical, registration phase, and post-marketing studies, including regulatory agency submission and agency meeting representation for accurate, accessible, and reproducible high quality clinical data. Our team makes sure biometrics operations meet the standards across a variety of different regulations, including: 21CFR, ICH GCP, US-FDA and more.
Our biostatistician offers services such as study design (including protocol review), study sample size, randomization schedule and CRF review, analysis plan, TLF mock shell, etc.), analysis, programming, reporting, statistical consultation, and training. Their extensive experience in different therapeutic areas ensures that they can make significant contributions to the success of a study.
At Zephyr Tech, our Biostatisticians have a strong educational background from reputed Universities/Institutes with degrees in PhD and/or Masters in Statistics and majority of them have 5+ years of industry experience.
Tools and Systems
SAS
This is the most widely used statistical programming package in the pharmaceutical industry and is used for all statistical analyses and production of report outputs.
East/East Adapt®
Design, sample size calculation, monitor, simulate, and modify studies utilizing an adaptive design
nQuery Advisor®
Sample size calculations
R Software
It is a preferred software for more complex statistical analysis, conducting study simulations and methods development
Define XML
Dataset review for electronic submissions.
Biostatistical Services
- Input into protocol
- Sample size calculations
- Randomization process
- CRF review prior to finalization
- Statistical Analysis Plan
- Methodology development
- CDISC ADaM and SDTM
- Electronic Submissions
- Analysis, table, figure, and listing programming
- Defining population analysis sets
- Independent QC/ Validation
- Statistical report
- Integrated Summary of Safety (ISS) and Efficacy (ISE)
- Development, documentation, and reporting
- Representing sponsor at agencies and regulatory authorities
- DMCs/DSMBs Statistical Analysis
- Safety review
- Interim analysis
- Meta-analysis
- Pharmacokinetics (PK) and Pharmacodynamics (PD)