Director, Biostatistics

Cardurion Pharmaceuticals•Burlington, MA

1d•$245,000 - $255,000

About The Position

Cardurion Pharma is a clinical-stage biotechnology company developing therapeutic approaches for cardiovascular disease. The Director, Biostatistics leads biostatistics activities for one or more clinical studies and provides statistical leadership to support accurate, timely, high-quality Biometrics deliverables and regulatory success. The role collaborates closely with statistical programming, pharmacometrics, data management, cross-functional teams, and external partners. The position leads statistical work across study design and execution, including target product profiles, innovative study design, modeling and simulation, sample size calculations, and preparation of study and regulatory documents. It also contributes to data monitoring and reviews, final study reports, and publications; evaluates biometrics tools and process improvements; stays current with statistical methods and regulatory guidance; and mentors junior biostatisticians and external consultants. Cardurion offers a competitive benefits package, including medical, dental, and vision coverage, retirement matching, paid insurance coverage, flexible spending accounts, paid time off, company holidays, and a year-end shutdown. The stated pay range is $245,000–$255,000.

Requirements

PhD in Biostatistics or a related scientific discipline.
At least 10 years of experience in biostatistics or a related area within the biopharmaceutical industry.
At least 3 years of experience designing and implementing innovative trial designs.
Experience 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 such as SAS or 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 guidelines.
Strong professional presence, focus, drive to succeed, confidence, passion, and high energy.
Strong interpersonal communication skills to collaborate effectively with colleagues, stakeholders, and vendors.

Responsibilities

Lead statistical activities for target product profiles, innovative study design, modeling and simulation, and sample size calculations.
Draft and contribute to synopses, protocols, case report forms, statistical analysis plans, and agency-submission briefing books.
Conduct written and direct interactions with agencies.
Coordinate with the broader Biometrics team and external Biometrics vendors to ensure deliverable quality, timeliness, and alignment with program objectives.
Provide statistical input into data monitoring plans and data reviews for assigned studies.
Review and contribute to final study reports and publications, ensuring appropriate statistical and data management procedures and interpretation.
Identify opportunities to improve business processes and procedures for greater speed, quality, efficiency, and output.
Evaluate Biometrics tools to meet program needs efficiently and effectively.
Stay current on emerging statistical methodologies and regulatory guidance, including 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.

Benefits

Blue Cross Blue Shield PPO medical coverage
Delta Dental coverage
VSP vision coverage
Fully funded HSA for the high-deductible PPO plan
401(k), traditional and Roth, with a 100% match on the first 4% deferred; match is immediately vested
Company-paid life insurance
Company-paid short-term and long-term disability insurance
Flexible Spending Accounts for medical and dependent care expenses
Four weeks of paid time off annually
11 company-paid holidays
Year-end shutdown