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.