Senior Biostatistics Leader for Cardio Trials

Cardurion Pharmaceuticals, Inc.; Burlington (MA); On-site; USD 245,000 - 255,000; Full time

Benefits offered by this job

Blue Cross Blue Shield PPO

Delta Dental

VSP vision

Fully funded HSA

401k with 100% match on first 4%

Life insurance

Short-term and long-term disability

Flexible Spending Accounts

4 weeks Paid Time Off

11 company paid holidays

Year-End shut down

Job summary

Cardurion Pharmaceuticals, Inc. in Massachusetts invites a senior biostatistician to lead biometrics for multiple clinical studies, shaping trial design, analysis plans, and regulatory submissions.

You will collaborate across functions and with external partners to ensure high-quality deliverables. An expert in CDISC standards, SAS, and R, you will mentor junior biostatisticians, oversee data interpretation, and stay current with regulatory guidance to support NDA/BLA/MAA programs.

Qualifications

• PhD in Biostatistics or related scientific discipline.
• At least 10 years of experience in biostatistics within biopharma.
• 3+ years designing innovative trial designs.
• Experience in Phase 1-4 trials and NDA/BLA/MAA analyses.
• Hands-on with CDISC standards; proficient in SAS and R.
• Strong analytical, regulatory knowledge and communication skills.

Responsibilities

• Lead statistical activities for study design, synopses, protocols and SAPs.
• Coordinate with biometrics team and external vendors for deliverables.
• Provide input to data monitoring plans and data reviews.
• Review final study reports and publications for correct interpretation.
• Improve efficiency of biometrics processes and assess tools.
• Stay current on regulatory guidance and apply to analyses.
• Provide mentorship to junior biostatisticians and consultants.

Skills

Biostatistics leadership

Clinical trial design

Analytical thinking

Interpersonal communication

Education

PhD in Biostatistics

Tools

SAS

R

CDISC standards

Job description

Cardurion Pharmaceuticals, Inc. in Massachusetts invites a senior biostatistician to lead biometrics for multiple clinical studies, shaping trial design, analysis plans, and regulatory submissions.

You will collaborate across functions and with external partners to ensure high-quality deliverables. An expert in CDISC standards, SAS, and R, you will mentor junior biostatisticians, oversee data interpretation, and stay current with regulatory guidance to support NDA/BLA/MAA programs.