Senior Software Engineer

The role

We're hiring a Senior/Principal Biostatistician to translate the biostatistics and statistical programming workflows you've spent a career mastering into the automation logic at the heart of our product. You'll work directly alongside our statistical programmers, biostatistics SMEs, and engineering team, sharing ownership of the domain skills that power the engine — and making sure they hold up in real clinical-trial workflows. We want someone driven to translate their expertise rather than re-execute it, and to help define how this work gets done for the next decade. This role reports to our Executive Director of Biostatistics.

What You'll Do

• Author the domain skills that power the engine: modular automation that encodes real statistical workflows and decision logic across SAP authoring, SDTM review, ADaM specification and programming, TLF shell annotation, and TLF programming/review.
• Set the standard the platform conforms to: ensure outputs are operationally realistic, consistent with industry practice, and credible to sponsors and regulators, including consistency between the skills you author and those authored by others.
• Turn analysis requirements into product: partner with engineering and product to translate clinical analysis needs into features, with detailed specs and tight iterative feedback through every development cycle.

What We're Looking For

• Experience: 7+ years leading and executing the biostatistics and statistical programming components of clinical trials.
• Regulatory fluency: deep command of the guidelines governing statistical analysis in the clinical-trial space, and an instinct for what a reviewer might flag.
• CDISC mastery: fluent in SDTM, ADaM, and the supporting metadata and documentation that make them a complete, submission-ready package.
• Adaptability: you've managed mid-study changes of varying scope — protocol amendments, CRF amendments — and you know how they ripple downstream into the analysis.
• Range: comfortable with the adjacent documents that shape statistical preparation even when biostatistics doesn't author them — study protocols, CRFs, EDC build specs, external vendor transfer agreements.
• Conviction: you'd rather encode your expertise , at a standard and level of quality you fully believe in, than re-execute it for the hundredth study. You want to set the standard, not absorb the inefficiency one more time.

Why join now

This is an exciting time in the pharmaceutical industry, as companies work towards technological advances and efficiencies. At idaptiq, we have proven founders with deep domain expertise covering biostatistics in clinical trials, AI/ML products in regulated healthcare environments, and building billion dollar software data businesses. They’ve brought together an amazing cross functional team of domain experts and engineers who are actively working to bring the idaptiq platform to life. Additionally, we have active design partnerships with established CROs, where we’re able to get direct user feedback to ensure we’re building a product that our users love in the context of real-world clinical trial biostatistic workflows. You'd be among the earliest and most impactful SME voices in the company, defining the function rather than inheriting it.