Director, Biometrics

The Director of Biometrics will play a hands-on role in the design, analysis, and interpretation of clinical and preclinical studies. This position involves direct involvement in statistical programming, data analysis, and collaboration with cross-functional teams to ensure the integrity and accuracy of our data, supporting regulatory submissions, and advancing our therapeutic programs.

This is a great opportunity to be involved in all aspects of drug development and transformation of a pioneer in today’s immuno-oncology field.

• Establishes and leads a premier Biometrics department, attracting, developing, and retaining top talent in Data Management, Biostatistics, and Statistical Programming.
• Actively engages in the design and analysis of clinical trials and preclinical studies.
• Develops and implements 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.
• Fosters synergies between functional areas to support the efficient development of high-quality study deliverables.
• Provides 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.
• Works with internal and external stakeholders in the design, collection, analysis, reporting, interpretation, and publication of clinical trial data.
• Leads, guides, and manages Biostatistics, Data Management, and Statistical programming teams, including contractors, to ensure high-quality and timely deliverables; develops budgets, sets priorities, ensures consistency and adherence to standards, and creates departmental SOPs.
• Drives the development and implementation of new innovations, standards, processes, and programming efficiencies across biometrics.
• Maintains 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.
• Oversees 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.
• Identifies quality issues and collaborates with Quality Assurance to develop and implement appropriate corrective action plans, escalating findings and action plans to appropriate parties.
• Provides 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.
• Monitors the qualitative and quantitative progress of biometrics implementation activities; oversees study reporting and tracks key indicators for performance and progress evaluation.
• Ensures consistent use of study tools, training materials, and compliance with standard processes, policies, and procedures.
• Other duties as assigned or deemed necessary by management

• Ph.D. or Master's degree in Biostatistics, Statistics, or a related field.
• Minimum of 8 years of experience in biostatistics within a similar biotech or pharmaceutical environment, with at least 3 years in a leadership role.
• Expertise in biological drug development with similar level experience in all phases of oncology clinical trials (preclinical to phase III).
• Proven track record of successful regulatory submissions and interactions with health authorities.
• Expertise in statistical software (e.g., SAS, R) and data management tools including knowledge of main EDC platforms
• Experience with CDISC standards
• Strong problem-solving skills and attention to detail.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively in a fast-paced, dynamic environment.

Job Type: Full-time

Benefits:

·         401K

·         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 X%

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.