Auratron delivers elite clinical SAS programming talent and expert statistical services to pharmaceutical, biotech, and CRO organizations — from SDTM and ADaM development to regulatory submission-ready deliverables.
From first-in-human Phase I studies to complex NDA/BLA regulatory submissions, Auratron brings the technical rigor and hands-on experience that clinical data demands. We do not cut corners — ever.
Full clinical trial lifecycle coverage — from protocol to final submission package
Auratron was founded by clinical statisticians and SAS programming veterans with deep roots in pharmaceutical and biotech drug development. We exist to bridge the critical gap between complex clinical trial data and regulatory-ready outputs.
Whether you need a single experienced SAS programmer embedded in your team or a full-service statistical programming engagement from SDTM mapping through ISS/ISE submission, Auratron delivers with precision, accountability, and speed.
We work exclusively in clinical trial biometrics. Every consultant and service offering is purpose-built for pharma, biotech, and CRO environments.
Our talent pool is pre-vetted, CDISC-trained, and ready to contribute from day one — reducing your time-to-productivity on critical deliverables.
Every output undergoes rigorous independent QC validation. We follow SDLC principles and maintain complete audit-ready documentation throughout.
We function as both a staffing partner — placing expert SAS clinical programmers within your teams — and as a full-service programming shop that delivers outputs directly. Choose what fits your project.
We identify, screen, and deploy pre-vetted SAS clinical programmers on a contract basis — from 3-month engagements to multi-year FSP arrangements. Candidates are matched precisely to your therapeutic area, phase, and technology environment.
Building an internal biometrics team? We source, assess, and present senior-level SAS programmers and biostatisticians for permanent roles — leveraging our deep network across pharma, biotech, and CRO sectors nationwide.
For organizations managing high-volume programming workloads, our FSP model embeds a fully managed team of Auratron programmers within your operations — delivering consistent capacity with centralized oversight and governance.
Submission crunch? Database lock approaching? We provide rapid-response placement of experienced programmers for time-critical interim analyses, database lock support, and regulatory submission sprint teams.
Seeking a Director of Statistical Programming, Head of Biometrics, or Senior Biostatistician? Our executive search practice specializes in leadership-level clinical data science roles across the full drug development spectrum.
Launching a biometrics department or scaling a new therapeutic area? We architect and staff complete programming teams — including programmers, leads, QC validators, and statistical analysts — tailored to your project pipeline.
We map raw clinical data to CDISC SDTM standards — covering all standard and non-standard domains, SUPPQUAL datasets, define.xml, and reviewer guides — ensuring Pinnacle 21 compliance and FDA/PMDA submission readiness.
Our programmers develop ADSL, ADAE, ADLB, ADCM, ADTTE, ADRS, and all BDS/OCCDS ADaM datasets — with full traceability from SDTM, adherence to ADaM IG, and complete programming specifications documentation.
From SAP-driven programming specifications to final validated outputs, we generate all efficacy and safety tables, listings, and figures — with complete independent QC validation ensuring every number and format is submission-ready.
We provide end-to-end submission programming for NDA, BLA, IND, and MAA filings — including ISS and ISE development, BIMO listings, Study Data Reviewer's Guide (SDRG), Analysis Data Reviewer's Guide (ADRG), and eCTD packaging.
Dissatisfied with your current CRO's output quality? We step in to salvage in-progress studies, revert non-compliant datasets, and convert legacy data to current CDISC standards — restoring timeline confidence without sacrificing data integrity.
We provide unbiased independent verification of SDTM datasets, ADaM programs, TLF outputs, and define.xml documents — validating statistical programming deliverables against SAPs and CDISC guidelines prior to regulatory submission.
Our team has worked through regulatory submissions to the FDA, EMA, and PMDA across oncology, inflammation, rare disease, and CNS — we understand the depth that clinical programming demands.
Full SDTM implementation including standard domains (AE, CM, LB, VS, EX, MH, DS, TU, TR, RS), SUPP datasets, trial design datasets, and FDA technical conformance compliance.
Complete ADaM programming: ADSL, ADAE, ADLB, ADCM, ADTTE, ADRS, ADVS, ADPFT, ADPC — built for traceability, replicability, and regulatory review efficiency.
Submission-ready TLF production using SAS PROC REPORT, SAS/GRAPH, and GTL — including KM survival plots, forest plots, waterfall plots, shift tables, and complex safety summaries.
Define.xml v2.0/2.1 generation, annotated CRF (aCRF) linkage, SDRG/ADRG authoring, and Study Data Reviewer's Guide development aligned to FDA technical conformance guidance.
Programming specification development from SAP, mock shell creation, estimand framework implementation, and full SAP-to-output traceability documentation for regulatory submissions.
Pinnacle 21 Enterprise validation, CDISC compliance report resolution, FDA rejection prevention, and technical conformance guidance interpretation and implementation.
Integrated Summary of Safety and Efficacy programming — pooled multi-study analyses, integrated ADaM datasets, cross-study TLF production, and submission-ready integrated packages.
Oncology, hematology, dermatology, inflammation, rare disease, CNS, cardiovascular, and infectious disease — deep familiarity with endpoint types, PRO instruments, and study designs across areas.
"The difference between a good submission and a rejected one often comes down to a single programmer who truly understands CDISC standards at depth — not just the mechanics, but the regulatory intent behind them."
— Auratron Clinical Programming PhilosophyWe are not a generalist agency placing warm bodies. We are clinical data specialists who happen to staff and program — and that distinction changes everything for our clients.
Unlike broad life sciences agencies, every search and every deliverable we touch is within statistical programming, biostatistics, and clinical data management. Our recruiters are not learning your world — they live in it.
Every candidate in our network has been technically assessed against CDISC SDTM/ADaM standards, PROC REPORT proficiency, and regulatory submission experience before they reach you.
Our team and consultants have contributed to successful NDA, BLA, and MAA submissions across multiple therapeutic areas. We understand the pressure, the timelines, and the regulatory stakes involved.
Staff augmentation, full project delivery, FSP, or hybrid — we structure engagements around your organization's workflow, governance, and budget. No rigid one-size-fits-all contracts.
Areas of Placement & Delivery
Whether you are a pharma organization that needs top-tier SAS talent or an experienced clinical SAS programmer ready for your next engagement, Auratron is your partner.
Pharmaceutical companies, emerging biotechs, and CROs trust Auratron to deliver qualified, immediately productive statistical programming talent — on the schedule your trials demand.
We represent experienced clinical SAS programmers and connect them with compelling contract and permanent opportunities at pharma, biotech, and CRO organizations across the US — with full support throughout.
From first conversation to delivered output — straightforward, efficient, and built around your timeline.
We understand your study phase, timeline, CDISC version, and programming environment requirements.
We identify candidates from our vetted network matched precisely to your technical needs and therapeutic area.
Client interviews and optional SAS technical assessments confirm fit before any contract is executed.
Smooth system access, documentation review, and rapid integration into your programming environment.
Ongoing account management, quality monitoring, and responsive support for the duration of the engagement.
"Auratron placed a senior SAS programmer who hit the ground running on day one. Our Phase III SDTM and ADaM deliverables were completed ahead of schedule with zero Pinnacle 21 critical findings."
"We needed ISS/ISE programming support for a BLA submission under an extremely tight timeline. Auratron not only delivered — they brought a level of CDISC depth that far exceeded our expectations."
"After a failed CRO engagement left us with non-compliant SDTM datasets and a looming submission deadline, Auratron's team rescued the project and delivered a clean, FDA-ready package."
Whether you need to staff a critical programming position, need a full SDTM/ADaM/TLF engagement, or simply want to understand how Auratron can support your next clinical program — reach out and let's start the conversation.