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Next-gen CRO with accountability built in, engineered to give sponsors confidence & control over their clinical studies
DSMB Statistician
Location
United States
Posted
40 days ago
Salary
0
Seniority
Mid Level
Job Description
DSMB Statistician
Lindus
Role Description 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 - Provide evidence-based recommendations on study continuation, modification, or termination against predefined FDA stopping criteria - Work 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. Qualifications - Ph.D. or Master's degree in Biostatistics, Statistics, or a closely related field - Prior experience serving on a DSMB or Data Monitoring Committee (DMC), ideally for FDA-regulated studies under IDE/PMA or IND pathways - Strong working knowledge of sequential interim analyses, group sequential designs, and stopping rule boundaries - Familiarity with Software as a Medical Device (SaMD), mobile health applications, or contraceptive and reproductive health studies (highly desirable, though not essential) - Free of significant conflicts of interest (financial, professional, or personal) with the study sponsor or the product under evaluation - Reliable and discreet, understanding the importance of maintaining strict confidentiality around unblinded interim data and closed board discussions - Embodies Lindus Health values: Be Transparent, High Agency, and Benefit Patients Requirements - Evaluate periodic interim analysis reports covering safety, efficacy, and data quality - Assess study progress against FDA-recommended stopping boundaries and safety thresholds - Participate in closed DSMB sessions to discuss findings with fellow board members - Contribute to the formulation of official DSMB recommendations to the sponsor - Maintain strict confidentiality regarding all unblinded interim data, deliberations, and board recommendations Benefits - Competitive 1099 rate tied to the engagement - Flexible, ad-hoc engagement model designed to fit around your clinical practice - Direct exposure to a high-quality portfolio of clinical trials and innovative sponsors - The chance to shape how respiratory research is run - A collaborative, mission-driven culture where your clinical expertise is genuinely valued Company Description We're powering biology's century with radically faster, more reliable clinical trials. 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. When you join us, you’ll experience: - High-Impact, Mission-Driven Work - Fast-Paced Growth & Ownership - Collaborative, No-Ego Culture
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