Biostatistics & Statistical Programming for CROs & Pharma

R-based biostatistics for CROs and sponsors: statistical analysis plans, CDISC-aware ADaM-style derivations, TLF production with gtsummary and rtables, double-programming QC, and submission-ready reproducible reporting.

Overflow capacity when your statistical programming queue is full. Independent biostatistics when a sponsor asks for it. TLFs, analysis datasets and reports produced in R β€” scripted, double-programmed and reproducible end to end. We speak the language of your SOPs: estimands, analysis populations, traceability and QC evidence, not just p-values.

Talk to a biostatistician, not a sales team

Ask for a free 20-minute scoping call β€” describe the study, the deliverable and the deadline, and we’ll tell you honestly whether we can help and by when. Get in touch β†’

What we deliver

Services for CROs & sponsors

Tables, listings & figures

Demography and baseline tables, AE summaries by SOC and PT, lab shift tables, Kaplan-Meier and forest plots β€” produced from mock shells with gtsummary, rtables and gt, exported to Word, PDF or HTML exactly as the shell specifies. See the TLF gallery β†’

CDISC-aware analysis datasets

ADaM-style derivations in R with the pharmaverse toolchain (admiral): analysis populations and flags, treatment variables, time-to-event derivations β€” every variable traceable from source to output. ADaM derivation walkthrough β†’

SAPs & estimands

Statistical analysis plans written to ICH E9(R1): estimand definition with intercurrent-event strategies, analysis-set definitions (ITT, mITT, per-protocol, safety), planned sensitivity analyses and mock shells that programmers can implement without guesswork. Clinical trial cheat sheet β†’

Double-programming QC

Independent reproduction of tables and datasets from the specifications β€” the QC evidence your SOPs require, with a documented comparison log. We slot into your existing validation framework rather than asking you to adopt ours.

Sample size, DSMB & interim support

Power and sample-size justification for protocols, re-estimation at interim, and independent reporting for data safety monitoring boards β€” delivered as reproducible Quarto reports the board can interrogate. Sample-size calculator β†’

SAS to R migration

Moving statistical programming from SAS licences to a validated R stack β€” parallel runs, double programming and a PROC-by-PROC equivalence map, so the transition is auditable rather than a leap of faith. The migration guide β†’

Why R, and is it accepted?

Regulatory-grade R

R is accepted by regulators: the FDA has received and reviewed fully R-based submissions through the R Consortium Submissions Working Group pilots, and the pharmaverse packages we use (admiral, rtables) are developed openly by the industry itself β€” Roche, GSK, J&J and others. β€œValidated” is a property of your process, not of a software licence: our deliverables come as version-pinned, scripted pipelines with session information and QC logs, ready to drop into a GxP-style quality system. More on this in our note on FDA R submissions.

Run it yourself

Try clinical R live β€” right here

This is real R, running in your browser via WebAssembly β€” nothing installed, nothing uploaded. A Kaplan-Meier fit and a log-rank test on the classic lung cohort; edit anything and press Run Code:

Want the Table 1 experience instead? The gtsummary live demo builds a baseline characteristics table you can edit line by line β€” the same package we use for TLF deliverables.

Proof, not promises

See the work

  • TLF gallery β€” mock shell on the left, R output on the right.
  • Clinical R toolkit β€” Table 1, adjusted odds ratios, Cox models and diagnostic accuracy, with the exact code.
  • Clinical cheat sheets β€” estimands, analysis sets, survival, missing data; free PDFs.
  • Case studies β€” sample-size planning and survival analysis engagements.
  • How we work β€” scoping call, fixed written proposal, the work, documented handover.

Need capacity this quarter?

Tell us the study design, the deliverable list and the timeline β€” we reply within two business days with an honest read and a fixed quote. Contact us β†’