Senior Director, Biometrics

7 days ago

San Diego, California, United States Janux Therapeutics Full time $264,000 - $280,000 per year
The Senior Director, Biometrics will provide strategic leadership and vision for the Biometrics function, overseeing the design, analysis, and interpretation of clinical and preclinical studies. This role is responsible for setting departmental strategy, driving innovation, and ensuring the highest standards of data integrity and regulatory compliance. The Senior Director will serve as a key advisor to executive leadership and represent the company externally at scientific and industry forums. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
  • Establish and lead a premier Biometrics department, attracting, developing, and retaining top talent in 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.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES
  • 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.
$264,000 - $280,000 a year In addition to a competitive base salary ranging from $264,000 to $280,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity. Job Type: Full-time   Benefits: · K · Medical insurance · Dental insurance · Vision insurance · Supplemental disability insurance plans · Flexible schedule · Life insurance · Flexible vacation · Sick time · Incentive stock option plan · Relocation assistance   Schedule: · Monday to Friday   Work authorization: · United States (Required)   Additional Compensation: · Annual targeted bonus %   Work Location: · On site (San Diego, CA)   EQUAL OPPORTUNITY EMPLOYER: Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

Notice to Recruiters and Third-Party Agencies The Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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