Director of Biostatistics

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

The Director of Biostatistics will lead statistical strategy and execution across clinical development programs, ensuring robust study design, analysis, and interpretation to support regulatory submissions and business objectives. This role provides expert guidance on statistical methodologies, oversees internal and outsourced biostatistical activities, and partners cross-functionally to deliver high-quality, compliant analyses. The Director will represent Biostatistics in regulatory interactions, contribute to clinical protocols and analysis plans, and drive innovation in statistical standards and processes. This position requires strong leadership, technical expertise, and the ability to manage complex projects in a fast-paced environment.

Responsibilities:
• Lead and coordinate statistical related activities to support clinical studies including but not limited to supporting the design, execution, analysis, interpretation, and reporting of clinical trials as well as communication of data evidence.
• Support is the statistical aspects of business-critical and/or regulatory commitments, provides input to program plans, and represent the Biostatistics function for cross-functional and intra-departmental teams or working groups.
• Functions as the lead statistician for assigned clinical projects.
• Performs management of in-house and/or outsourced biostatistical activities.
• May engage with regulatory authorities on compound/indication level discussions.
• Prepare or review the clinical study protocols, case report forms, statistical analysis plans, and table shells as needed.
• Create programs for data management activities, compliant analysis datasets, and statistical analysis of the clinical trial data.
• Prepare the statistical section of clinical trial reports and presentations of the results to the team.
• Demonstrate solid understanding of regulatory guidance and statistical methodology as applied to clinical studies in pharmaceutical development.
• Presenting interim trial data to Data Monitoring Committees (DMCs).
• Writing statistical reports and memos with minimal guidance.
• Programming complex datasets.
• Leading or supporting complex analyses, including efficacy and futility interim analyses for DMCs.
• Supports the preparation and documentation of statistical analyses to enable management to write and support trial reports and publications.
• Helps ensure that new and revised statistical standards, tests, and processes are implemented for increased accuracy and efficiency.
• Reviewing statements of work, proposals, and budgets.
• Managing multiple projects and a majority of own workload.
• Perform such other duties as may be assigned from time to time.

Requirements:
• Master's Degree in statistics, biostatistics or a closely related field; PhD preferred
• 7+ years clinical trials experience
• Experience with rare disease and NDA/BLA submission preferred
• Strong knowledge of statistical software packages including SAS and other applications such as R, and SQL
• Strong knowledge of therapeutic area and acute care/hospital trial settings preferred
• Demonstrates strong leadership and management skills
• Ability to write and articulate clearly
• Strong sense of urgency and commitment to excellence in the successful achievement of defined project objectives
• Ability to prioritize workload to meet multiple project timelines
• Excellent planning and organization skills
• Excellent problem-solving abilities
• Ability to function independently and exercise judgment and decision-making skills

Why Capricor?
Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.

Come Work With Us!
At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.

Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.

Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.