DSMB Statistician

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.

Responsibilities

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

Requirements

• 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.

Qualifications

• High-Impact, Mission-Driven Work: Lindus is disrupting an outdated industry, giving you the chance to directly improve patients’ lives and see tangible results from your work.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 recognize 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.

Skills

• Strong statistical and analytical skills.
• Experience with regulatory guidelines and standards.
• Familiarity with mobile health applications and contraceptive studies.

Benefits

• 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.

Pay

Competitive 1099 rate tied to the engagement, with flexibility to focus on the trials and topics where your expertise adds the most value.

Schedule

A flexible, ad-hoc engagement model designed to fit around your clinical practice — no minimum hours, no commitment to a fixed schedule.