ED Biostatistics

We have a current opportunity for an ED Biostatistics on a permanent basis.

For further information about this position please apply.

Executive Director, Biostatistics

Company Overview

An established mid-sized pharmaceutical firm located in Pennsylvania, dedicated to advancing healthcare through innovative drug development and clinical research. Our mission is to improve patient outcomes by delivering high-quality, effective, and safe pharmaceutical products.

Location: Pennsylvania, USA (3x a week onsite)

Salary: 290,000-330,000 base + additional benefits

Job Summary

The Executive Director of Biostatistics is an individual contributor that will lead multiple biostatistical activities for covering all phases of clinical development. This position will be a combination of conducting complex statistical analyses, developing SAPs and contributing to regulatory documents.This role involves collaboration with cross-functional teams to ensure the integrity, quality, and compliance of statistical analyses and reporting.

Key Responsibilities

• Leadership and Management:

  • Lead and mentor a team of biostatisticians, ensuring professional development and high performance.
  • Develop and implement biostatistical strategies aligned with the company's goals and regulatory requirements.
  • Represent the biostatistics function in senior management meetings and decision-making processes.

• Clinical Trial Design and Analysis:

  • Provide expert guidance on the design, analysis, and interpretation of clinical trials.
  • Ensure the statistical integrity and scientific validity of clinical trial data.
  • Collaborate with clinical, regulatory, and medical teams to develop study protocols and statistical analysis plans.

• Regulatory Submissions:

  • Oversee the preparation and review of statistical sections for regulatory submissions (e.g., IND, NDA, BLA).
  • Ensure compliance with regulatory guidelines and standards (e.g., FDA, EMA).
  • Participate in meetings with regulatory agencies to discuss statistical aspects of submissions.

• Data Management and Reporting:

  • Ensure accurate and timely statistical analysis and reporting of clinical trial data.
  • Develop and maintain standard operating procedures (SOPs) for biostatistical activities.
  • Implement and oversee data management practices to ensure data quality and integrity.

• Collaboration and Communication:

  • Foster strong collaborative relationships with internal and external stakeholders.
  • Communicate complex statistical concepts and results to non-statistical audiences.
  • Provide strategic input to clinical development plans and product lifecycle management.

Qualifications

• Education:

  • PhD in Biostatistics, Statistics, or a related field.

• Experience:

  • Minimum of 15 years of experience in biostatistics within the pharmaceutical or biotechnology industry.
  • Proven track record of leading biostatistical teams and managing biostatistical activities for clinical trials.
  • Extensive experience with regulatory submissions and interactions with regulatory agencies.

• Skills:

  • Strong leadership and team management skills.
  • Expertise in clinical trial design, statistical analysis, and data interpretation.
  • Excellent communication and interpersonal skills.
  • Proficiency in statistical software (e.g., SAS, R) and data management systems.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with company match.
• Professional development opportunities and continuing education support.
• Flexible work arrangements and work-life balance initiatives.