Director, Biostatistics

We are a clinical-stage biotechnology company discovering and developing new therapeutic approaches to treat cardiovascular disease. We have built a pipeline of novel therapeutic product candidates that have the potential to address the significant morbidity and mortality that remains for patients suffering from cardiovascular disease. We invite you to explore our website to learn more about our Company and how we are advancing towards our goal of building a world-class biotechnology company that discovers, develops and commercializes life-changing therapeutics for patients with cardiovascular disease.

Responsible for leading biostatistics activities for one or more of Cardurion’s clinical studies. This role will coordinate closely with statistical programming, pharmacometrics, and data management colleagues on the assigned program, and work collaboratively with cross-functional teams and external partners — providing statistical leadership to ensure that all Biometrics deliverables are accurate, timely, consistent, and executed with the highest quality standard for regulatory success.

• Lead statistical activities for target product profiles, innovative study design, modelling and simulation, sample size calculation, drafting of synopses, protocols, case report forms, statistical analysis plans, briefing books for agency submission, and written and direct agency interactions.
• Coordinate closely with the broader biometrics team (statistical programming, pharmacometrics, and data management) and external biometrics vendors to ensure the quality and timeliness of deliverables and alignment with program objectives.
• Provide statistical input into data monitoring plans and data reviews for the assigned studies.
• Review and contribute to final study reports and publications to ensure appropriate use of statistical and data management procedures and interpretation.
• Identify opportunities to improve the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output. Evaluate biometrics tools to efficiently and effectively meet program needs.
• Stay current on emerging statistical methodologies and regulatory guidance (e.g., ICH E9/E9(R1)) and apply relevant developments to study design and analysis strategy.
• Provide technical guidance and mentorship to junior biostatisticians and external consultants.

• Highly competitive benefits package including:
  Blue Cross Blue Shield PPO, Delta Dental, and VSP vision
• Fully funded HSA for high-deductible PPO Plan
• 401k (traditional and Roth offered) with 100% match on first 4% deferred. Match is vested immediately
• A suite of Cardurion paid insurance coverage, including: life insurance, short-term and long-term disability
• Flexible Spending Accounts for medical and dependent care expenses
• 4 weeks Paid Time Off annually
• 11 company paid holidays and Year-End shut down

$245,00 - $255,000

Job Type: Full-time

• Education:
  
  PhD in Biostatistics or related scientific discipline.
• At least 10 years of experience in biostatistics or related area within the biopharmaceutical industry, including at least 3 years of experience designing and implementing innovative trial designs.
• Experience in conducting Phase 1-4 clinical trials and integrated analyses for NDA/BLA/MAA.
• Thorough understanding of, and hands‑on experience implementing CDISC standards.
• Proficiency in statistical programming software (e.g., SAS, R) to support analysis, review, and validation of statistical deliverables.
• Strong analytical and problem‑solving skills, with expert knowledge of clinical trial design, statistical methodologies, and regulatory…