Senior Director, Biostatistics (Boston, MA)

Cedent Consulting Inc; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Senior Director of Biostatistics to lead a dynamic statistical team. This pivotal role involves overseeing statistical strategies that align with clinical objectives and regulatory standards. You will mentor a high-performing team, collaborate with cross-functional stakeholders, and implement innovative statistical methodologies to enhance trial efficiency. With a focus on maintaining data quality and compliance, you'll play a key role in shaping clinical development strategies and achieving organizational goals. If you are passionate about biostatistics and leadership, this opportunity is perfect for you.

Qualifications

• 10+ years of industry experience in biostatistics or statistics.
• Proven expertise in statistical methodologies for clinical trials.

Responsibilities

• Lead and develop a high-performing statistical team.
• Ensure accuracy and integrity of statistical analyses.
• Champion innovative statistical approaches for trial efficiency.

Skills

Leadership

Biostatistics

Statistical Analysis

Regulatory Compliance

Clinical Development

Innovative Trial Designs

Education

Ph.D. in Biostatistics or Statistics

Master’s degree in Biostatistics or Statistics

Job description

Position Summary:
As the Senior Director of Biostatistics, you will lead and develop the statistical team within the assigned disease area, ensuring statistical strategies align with clinical development objectives and regulatory standards. In this leadership role, you will oversee the development, execution, and interpretation of statistical analyses, maintaining data quality, analysis integrity, and compliance with regulatory requirements. Additionally, you will champion innovative trial designs and methodologies while fostering a collaborative, high-performing team culture. Reporting to the VP, Head of Biometrics, you will play a pivotal role in shaping clinical development strategy and achieving company goals.

Key Responsibilities:

1. Build, mentor, and lead a high-performing statistical team, fostering collaboration, learning, and accountability.
2. Provide strategic and statistical leadership as a core member of the clinical development team, collaborating with cross-functional stakeholders.
3. Partner with medical, regulatory, pharmacology, clinical operations, and other functions to implement appropriate statistical methodologies and analysis plans.
4. Champion innovative statistical approaches, such as adaptive, seamless, and Bayesian designs, to enhance trial efficiency and success rates.
5. Ensure the accuracy, integrity, and consistency of statistical analyses across clinical development programs, from Phase I through regulatory submissions and post-approval activities.
6. Contribute to the development and implementation of Standard Operating Procedures (SOPs) and workflows, ensuring regulatory compliance and adherence to industry best practices.
7. Oversee CRO activities, ensuring high-quality deliverables, adherence to timelines, and efficient use of resources.

Requirements:

1. Ph.D. in Biostatistics or Statistics with 10+ years of industry experience, or Master’s degree with 12+ years of experience.
2. Proven expertise in statistical activities for clinical development programs, including successful regulatory submissions (NDAs, BLAs, or equivalent).
3. Demonstrated leadership in applying innovative statistical methodologies to enhance clinical trial efficiency.