Job Description

About the Role

We're seeking an experienced Biostatistician to serve as an independent member of the Data and Safety Monitoring Board (DSMB) for an upcoming FDA-regulated clinical study. The study evaluates a mobile health (mHealth) application designed for menstrual period monitoring and contraceptive guidance.

As the independent statistical expert on the board, you'll play a critical role in ensuring participant safety and study integrity. You'll review interim analysis reports and provide evidence-based recommendations on study continuation, modification, or termination against predefined FDA stopping criteria — working alongside fellow board members including clinicians and epidemiologists.

This is a sporadic, as-needed engagement over an anticipated 18-month study duration, with approximately three DSMB meetings plus an initial organisational meeting. Each meeting cycle requires roughly 6–8 hours of effort including pre-meeting report review and meeting attendance.

About You

We'd like to hear from you if…

You hold a Ph.D. or Master's degree in Biostatistics, Statistics, or a closely related field.
You bring prior experience serving on a DSMB or Data Monitoring Committee (DMC), ideally for FDA-regulated studies under IDE/PMA or IND pathways.
You have a strong working knowledge of sequential interim analyses, group sequential designs, and stopping rule boundaries, and can apply these confidently in a regulatory context.
You're familiar with Software as a Medical Device (SaMD), mobile health applications, or contraceptive and reproductive health studies — highly desirable, though not essential.
You're free of significant conflicts of interest (financial, professional, or personal) with the study sponsor or the product under evaluation.
You're reliable and discreet: you understand the importance of maintaining strict confidentiality around unblinded interim data and closed board discussions.
You embody Lindus Health values: Be Transparent, High Agency, and Benefit Patients.

What You'll Focus On

Interim Data Review: Evaluate periodic interim analysis reports covering safety, efficacy, and data quality, and translate statistical findings into clear, actionable conclusions for the board.
Regulatory Alignment: Assess study progress against FDA-recommended stopping boundaries and safety thresholds, ensuring the board's oversight remains in line with applicable regulatory expectations.
Collaborative Decision-Making: Participate in closed DSMB sessions to discuss findings with fellow board members and reach well-reasoned, consensus-informed positions.
Formal Recommendations: Contribute to the formulation of official DSMB recommendations to the sponsor regarding study continuation, protocol amendments, or early termination.
Confidentiality: Maintain strict confidentiality regarding all unblinded interim data, deliberations, and board recommendations throughout the life of the study.

What We Offer

Competitive 1099 rate tied to the engagement, with flexibility to focus on the trials and topics where your expertise adds the most value.
A flexible, ad-hoc engagement model designed to fit around your clinical practice — no minimum hours, no commitment to a fixed schedule.
Direct exposure to a high-quality portfolio of clinical trials and innovative sponsors working in the respiratory and pulmonary space.
The chance to shape how respiratory research is run, partnering with a team that's genuinely changing healthcare for the better.
A collaborative, mission-driven culture where your clinical expertise is genuinely valued and acted on.

Employment Type: Contract
Location: US (Remote)
Department: Data

About the Company

Our mission

We're powering biology's century with radically faster, more reliable clinical trials. Every new treatment needs clinical trials to prove safety and efficacy, but today's infrastructure is stuck in the past- driving up cost, causing delays and ultimately meaning new treatments don't get to patients. We're fundamentally changing that- not just being a "better CRO," but transforming how people think about developing new treatments, so patients can access breakthrough treatments faster.

Our impact speaks for itself: Since March 2021, we've powered 100+ clinical trials involving tens of thousands of patients. We recently raised a $55M Series B from Balderton Capital, alongside backing from Creandum, Firstminute, Seedcamp, and Visionaries.

What's it like to work here?

When you join us, you'll experience:

High-Impact, Mission-Driven Work: Lindus is disrupting an outdated industry, giving you the chance to directly improve patients' lives and see tangible results from your work.
Fast-Paced Growth & Ownership: We recognise hard work and outcomes over anything else. You'll take on real responsibility, work across different areas, and actively shape the company's success.
Collaborative, No-Ego Culture: Work with smart, driven people in a supportive and informal environment. At Lindus we break down silos, fun is a core value, and creativity is encouraged.

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