Biostatistics & Statistical Programming
We deliver end-to-end biostatistics and programming support—ensuring rigorous study design, accurate analyses, and regulatory-compliant datasets that drive successful submissions.
A Biostatistics and Programming Center of Excellence
In today’s complex clinical research landscape, trial success depends not only on groundbreaking science but also on the precision and reliability of supporting data. Rigorous statistical planning and flawless execution are essential to driving successful trials and securing regulatory approval.
At Everest, our biostatistics and programming expertise provide the analytical foundation to protect data integrity, reduce risk, accelerate timelines, and ensure compliance. With decades of focus across therapeutic areas, trial designs, and phases, we’ve built a top-tier reputation for delivering excellence in statistical and programming execution.
How We Engage
We support biostatistics and programming needs in multiple ways. Our services range from turn-key project delivery to cross-program support as a centralized data and analytics partner. We also step in to rescue projects from under-performing teams or provide high-caliber staff through Functional Service Provider (FSP) models.
Single Study
Full-service, protocol-driven biostatistics and statistical programming for standalone trials—with the same rigor and responsiveness we’re known for:
Study-specific analysis plans tailored to your endpoints and design
Clean, timely deliverables without
long-term commitment
Expert statisticians and programmers who navigate complexity and reduce risk
Program-Level Support
As a long-term biostatistics and programming partner, we can bring strategic insight, alignment, and continuity across your clinical development:
Consistent methodology across studies for seamless data pooling and submission
Faster analysis timelines through standardized processes and templates
Cross-study knowledge transfer that improves quality and decision-making
Scalable support aligned with your evolving pipeline and resource needs
Rescue Studies
We step in quickly to resolve biostatistical challenges and ensure your study stays on track. Our rescue support includes:
Delivering high-quality, on-time outputs to replace delayed or incomplete deliverables
Rebuilding or realigning SAPs and mock shells for clarity and compliance
Performing urgent re-analyses and post-hoc support to meet submission or inspection needs
FSP
Dedicated statisticians and programmers embedded within your organization
Scalable resourcing that adapts to your pipeline needs
Consistency in processes, tools, and deliverables across studies and programs
Cost efficiency and continuity of knowledge without the overhead of multiple vendors
What We Offer
Our biostatistics and programming teams bring quality, consistency and seamless execution to your programs, supporting early planning/preparations through project delivery, regulatory submissions and agency support for NDA/BLA, medical device, and diagnostics marketing applications.
Trial Design & Planning
- Development program strategy (preclinical to Phase IV)
- Study design and protocol development
- Sample size calculation
- Statistical Analysis Plan (SAP) development
- Randomization strategy and implementation
Clinical Trial Execution
- Statistical programming (CDISC-compliant SDTM and ADaM datasets)
- QC of datasets, tables, listings, and figures (TLFs)
- Unblinded support for interim analyses and DSMB/DMC reviews
- PK/PD modeling and simulation
- Real-time and blinded analyses throughout the trial lifecycle
Submission & Regulatory Support
- NDA/BLA submission packages, including ISS/ISE
- Generation of define.xml, reviewer guides, BIMO reports
- Integration of legacy data and data standardization
- Statistical defense of regulatory submissions
Post-Trial & Publications Support
- Exploratory and post-hoc analyses
- Meta-analyses and signal detection
- Manuscripts, abstracts, and presentations in partnership with medical writing
- Support for IITs and HEOR studies
- Statistical consulting for due diligence and licensing activities
Why Choose Everest for Your
Biostatistics and Statistical Programming?
Founded on Biometrics
Statistics and programming have been core to Everest since day one. We bring nearly two decades of depth, discipline, and quality to every project.
Highly Trained and Technical Teams
Proven Quality
Regulatory and Compliance Expertise
High-touch Customer Service
Our Results
Years of supporting global pharma, biotech, and research institutions.
Of clients return for additional projects with us.
Nearly 100% of our biostatisticians hold advanced degrees (Master's degree and above).
Exceptional SAS Skills
Every biostatistician and programmer is required to take a SAS skills test prior to being hired, ensuring competency.
Partnerships Built on Quality and Flexibility
“Our longstanding partnerships with leading pharmaceutical, biotechnology, medical device, diagnostics companies, and research institutions worldwide underscore the trust placed in Everest to meet diverse and complex analytical needs. This confidence reflects our steadfast commitment to quality, customer focus, and flexibility—a culture that consistently delivers measurable value and enduring collaboration."
-Irene Zhang, Founder and Executive Chairman
