Director, Biostatistics

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

Description

Why join Cardurion Pharma?

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.

The Role:

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.

Here's What You'll Do:

• 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.

Here's What We'll Bring to the Table:

• 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

Pay Range:

$245,00 - $255,000

Requirements

Here's What You'll Bring to the Table:

• 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 guidelines.
• Strong professional presence, focus and drive to succeed, confidence, passion, and high energy.
• Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively.

Our Mission:

Translate our world-class expertise in cardiovascular signaling pathways into potentially groundbreaking therapeutics for patients.

Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Cardurion will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.