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Lindus Health
Data Science & Analytics 1d ago

Staff Biostatistician

Lindus Health
United StatesUnited States
Full-time
Not Disclosed
Senior-Level

Job Description

Key Skills Required

Master these to land this role

Clinical TrialsBiostatisticsRegulatory SubmissionsSASR

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We're looking for a Staff Biostatistician to be the senior technical authority on statistics at Lindus Therapeutics. This is a senior individual contributor role covering the full lifecycle of a drug asset: reviewing the evidence behind a potential acquisition, shaping trial design from the first draft of a protocol, owning the analyses that decide whether a programme moves forward, and representing that work directly to regulators.

This role matters because Lindus Therapeutics is built on a portfolio model: we're in-licensing several clinical-stage assets at once, each carrying real acquisition, design and regulatory risk. Without a senior statistician who can independently own that judgement across multiple programmes simultaneously, every asset decision slows down and waits on a single bottleneck. You'll take on the trials and acquisitions that carry the most complexity (adaptive designs, novel endpoints, multi-cohort studies), set the standards the rest of the team works from, and be the person others turn to when a decision needs to hold up under scrutiny.

You'll work closely with Clinical Operations, Data Architecture, Regulatory and Corporate Development leadership, and your input will shape decisions upstream on any individual trial or acquisition.

About you

We'd like to hear from you if…

  • You have high agency and a bias for action, with genuine passion for our mission of transforming how new health treatments are developed
  • You hold a PhD or Master's in Biostatistics, Statistics, or a related field, with 9+ years in clinical biostatistics, including preparing statistical content for an FDA submission (IND, NDA or BLA)
  • You have led statistical strategy across multiple trials independently, including complex or adaptive designs, and are fluent in R or SAS while directing others' programming work
  • You have led interim analyses with material go/no-go or safety consequences and represented statistical positions directly to regulators
  • You are a trusted, credible statistical voice with Clinical Operations, Regulatory and Corporate Development leadership, shaping decisions upstream on any given trial

You belong here! If your experience and interests match with some of the above, we want you to apply.

What you'll focus on

  • Asset acquisition diligence: Lead the statistical assessment on asset acquisitions and deliver the final statistical verdict that informs the decision.
  • Trial design leadership: Set the standard for trial design across the portfolio, leading design of the most complex trials and reviewing others' designs for structural risk.
  • High-stakes analysis & regulatory representation: Own the interim and final analyses with the greatest scientific, safety or business consequence, including direct board-facing responsibility, and serve as the senior statistical authority in regulatory interactions, authoring and defending the statistical case in briefing books, submissions and agency meetings.
  • Standards & mentorship: Build the statistical standards, templates and SOPs the rest of the team works from, lead their adoption, and mentor other statisticians as the biostatistics function grows.

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Lindus Health is a tech-enabled contract research organization (CRO) that accelerates and modernizes clinical trial execution for biotech, healthcare, and pharmaceutical companies. Founded in 2021 by Michael Young, Meri Beckwith, and Nik Haldimann, the company provides an end-to-end clinical trial management platform—Citrus™—covering study design, rapid patient recruitment, real-time data collection, and regulatory compliance to bring healthcare innovations to market faster.

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