DSMB Statistician

**🍊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to work here?** When you join us, you’ll experience: - **High-Impact, Mission-Driven Work:** Lindus is disrupting an outdated industry, giving you the chance to directly improve patients’ lives and see tangible results from your work.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. *Ready to power biology's century? We'd love to hear from you.* **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 clos…