ED Biostatistics


Conshohocken
Permanent
USD290000 - USD330000
Biometrics
PR/544084_1746477597
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.

FAQs

Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.

Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.

We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business. 

That's why we recommend registering your resume so you can be considered for roles that have yet to be created. 

Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.

Handpicked roles for you