We have a current opportunity for a Snr D/ ED Biostatistics on a permanent basis. The position will be based in Pennsylvania. For further information about this position please apply.
Job Title: Snr/Executive Director, Biostatistics
Report: Chief Data and Analytics Officer
Location: Pennsylvania, USA
Job Type: Full-Time
Overview: The Executive Director of Biostatistics will be an individual contributor that will lead multiple biostatistical activities, covering all phases of clinical development. This position will be a hands on role with a combination of conducting complex statistical analyses, developing SAPs and contributing to regulatory documents.
Key Responsibilities:
- Lead and manage the biostatistics team, fostering a collaborative and high-performing environment.
- Provide statistical expertise and strategic input for clinical development plans, study designs, and regulatory submissions.
- Ensure the quality and integrity of statistical deliverables, including protocols, statistical analysis plans (SAPs), and clinical study reports (CSRs).
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and data management, to support the company's therapeutic portfolio.
- Represent the company in external scientific and regulatory forums, demonstrating leadership and influencing industry standards.
- Drive continuous improvement initiatives within the biostatistics function to enhance efficiency and innovation.
Qualifications:
- PhD in Biostatistics, Statistics, or a related field.
- Minimum of 10+ years of relevant industry experience, with at least 3 years in a leadership role managing a global team
- Experience in Liver Diseases is preferred, but open to all TAs
- Strong expertise in statistical methodologies and their application in clinical trials.
- Experience with regulatory submissions and a thorough understanding of worldwide regulatory requirements.
- Excellent communication skills, both written and verbal, with the ability to explain complex statistical concepts to non-statisticians.
- Proven track record of leading high-performing teams and driving innovation in biostatistics.
