Statistical Programming
Zephyr Tech offers Statistical Programming services to support the analysis and reporting of clinical data. Our statistical programmers have years of experience performing analysis and reporting activities for Phase I to IV of clinical development, including Real World Evidence and Observational studies. They are skilled to provide functional expertise and leadership to clinical project teams to lead statistical programming teams throughout the project.
Our experienced statistical programmers provide consulting services for clinical trials and post-marketing studies, including support for regulatory agency submission (i.e., for NDA/BLA/MAA/PMDA) and agency rapid response ad-hoc requests. They provide end to end programming support starting from edit checks programming, patient profiles, patient narrative listings, CDSIC datasets, statistical outputs, and submission define.xml package. They are all trained on 21CFR, ICH GCP, CDISC standards.
They inherit years of experience in different therapeutic areas which helps them to adapt quickly to any project assignment.
Our statistical programmers are having strong educational background from reputed universities/institute with degrees in PhD, master’s in Statistics, master’s in public health, bachelor’s in science/Engineering/Pharmacy or relevant filet and majority of them have 5+ years of industry experience.
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Areas of Expertise
With expertise in the Biometrics domain, Zephyr Tech has a network of skilled EDC Developers/Clinical Programmers. If you have a need for one Clinical Programmer or a team, we can provide the resources at quickly. Our EDC Clinical Programmers have been providing services to our clients in the following areas:
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Radiation Therapy
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Nephrology and Renal Disease
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Hematology and Oncology
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Dermatology, Immunology & Inflammatory Diseases
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Internal Medicine
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Opthalmology
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Autoimmune Diseases
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Neuroscience
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Cardiovascular
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Endocrine and Metabolic
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Infectious Diseases and Vaccines
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NASH & Liver Disease Clinical Development
Tools and Systems
Our Statistical Programmers are experienced with various software 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.
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.
Focus Industries
Medical Devices
Biotech Firms
Clinical Companies
Pharmaceuticals
Research Labs
New Age Companies
Our Benefits
Choose the experts for your statistical programming needs. Hiring our readily available and certified team members will allow you to:
- Complete your projects on time
- Manage your time so you’ll get more done in less time
- Focus on development and operations rather than recruitment
- Cut expenses without sacrificing quality
- Automate your business, so you can leave for days, weeks, or even months at a time
Our Services
We offer full range of Statistical Programming services including following:
- CRF annotations
- Statistical Analysis Plan Review
- CDISC SDTM specifications and programming
- CDISC ADaM specifications and programming
- Pinnacle 21 checks
- Tables, Listings and Figures (TLFs) programming
- Independent QC/ Validation
- Integrated Summary of Safety (ISS) and Efficacy (ISE)
- Electronic Submissions
- SAS Macro Development and, documentation
- Ad-hoc requests
- DMCs/DSMBs TLFs
- Interim analysis TLFs
- Meta-analysis TLFs
- Legacy Dataset Package
- Pharmacokinetics (PK) and Pharmacodynamics (PD)
- R programming