DSMB Statistician

Lindus

3d

About The Position

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.

Requirements

• 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, and can apply these confidently in a regulatory context.
• Free of significant conflicts of interest (financial, professional, or personal) with the study sponsor or the product under evaluation.
• Reliable and discreet: understand the importance of maintaining strict confidentiality around unblinded interim data and closed board discussions.
• Embody Lindus Health values: Be Transparent, High Agency, and Benefit Patients.

Nice To Haves

• Familiarity with Software as a Medical Device (SaMD), mobile health applications, or contraceptive and reproductive health studies.

Responsibilities

• Evaluate periodic interim analysis reports covering safety, efficacy, and data quality, and translate statistical findings into clear, actionable conclusions for the board.
• Assess 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.

Benefits

• Competitive 1099 rate tied to the engagement
• Flexibility to focus on the trials and topics where your expertise adds the most value
• 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

What This Job Offers

• Career Level: Senior
• Education Level: Ph.D. or professional degree