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Janux Therapeutics · 3 months ago

Senior Director, Biometrics

San Diego, CA

Full-time

Onsite

Director/Executive

$264K/yr - $280K/yr

10+ years exp

Janux Therapeutics is seeking a Senior Director, Biometrics to provide strategic leadership and vision for the Biometrics function. This role involves overseeing the design, analysis, and interpretation of clinical and preclinical studies, setting departmental strategy, and ensuring data integrity and regulatory compliance.

BiotechnologyHealth DiagnosticsPharmaceuticalTherapeutics

Responsibilities

Establish and lead a premier Biometrics department, attracting, developing, and retaining top talent in Data Management, Biostatistics, and Statistical Programming

Actively engage in the design and analysis of clinical trials and preclinical studies

Lead cross-functional initiatives to advance clinical development and regulatory success

Develop and implement statistical analysis plans, including hands-on statistical programming and data analysis as needed

Collaborates closely with Clinical Development and Operations, Regulatory Affairs, Biomarkers, and Data Management teams to ensure robust study designs and accurate data interpretation

Foster synergies between functional areas to support the efficient development of high-quality study deliverables

Provide statistical input and support for regulatory submissions and interactions with health authorities

Ensures the statistical integrity of protocols, statistical analysis plans, clinical study reports, presentations, and publications of clinical trial data

Work with internal and external stakeholders in the design, collection, analysis, reporting, interpretation, and publication of clinical trial data

Set the strategic direction for the Biometrics department, aligning goals with organizational objectives and long-term growth; develop budgets, set priorities, ensure consistency and adherence to standards, and create departmental SOPs

Drive the development and implementation of new innovations, standards, processes, and programming efficiencies across biometrics

Maintain a broad understanding of relevant external trends, anticipates emerging issues, identifies strategic needs in technical knowledge, and sets the strategic direction to meet regulatory, scientific, and business needs

Oversee CRO biometrics deliverables, including but not limited to database and CRF development, statistical analysis plans, and interim and final TLF deliverables, ensuring quality and alignment with organizational goals and objectives

Represents the organization at professional societies, external scientific forums, and industry-wide technical discussions, as applicable

Ensure the statistical integrity of all deliverables and compliance with regulatory requirements

Lead quality assurance initiatives and corrective action planning

Provide expertise and consultation as a subject matter expert to project teams and serves as a key point of contact with senior management to continuously assess and improve operational project delivery

Monitor the qualitative and quantitative progress of biometrics implementation activities; oversees study reporting and tracks key indicators for performance and progress evaluation

Ensure consistent use of study tools, training materials, and compliance with standard processes, policies, and procedures

Other duties as assigned or deemed necessary by management

Qualification

BiostatisticsStatistical softwareDrug developmentStatistical planningData management toolsCross-functional leadershipExecutive presenceCommunication skillsInterpersonal skills

Required

Ph.D. or Master's degree in Biostatistics, Statistics, or a related field

Minimum of 10 years of experience in biostatistics within biotech or pharmaceutical environments, with 5+ years in a senior leadership role

Demonstrated success in leading biometrics teams through all phases of drug development, including regulatory submissions and health authority interactions

Strong Phase III statistical planning background

Proven track record of strategic planning, innovation, and cross-functional leadership

Expertise in statistical software (e.g., SAS, R), data management tools, EDC platforms, and CDISC standards

Strong executive presence, communication, and interpersonal skills

Ability to influence and collaborate at all levels of the organization