Penfield Search Partners
Our client is a clinical-stage company focusing on novel treatments for a variety of Rare Diseases. Currently they are looking for an Executive Director of Biometrics to lead a small and growing team – you would be a key agent in helping bring the Biometrics effort in house from a partially outsourced model. Reporting to the CMO, this is a visible, hands-on, cross-functional role with a real voice, a “seat at the table”. The ED, Biometrics will work with various teams (Clinical Development, Medical Affairs, Marketing, Regulatory Affairs, Business Development) in the design and conduct of clinical studies and in the evaluation, interpretation and preparation of study results. This role is located in the Bay Area and supports a hybrid remote/office-based model.
- Lead the biostatistics, programming and clinical data management groups with a clear vision and purpose; provide leadership and oversight to the biometrics function
- Ensure that program development teams obtain sufficient strategic input and technical expertise on statistical methodologies for clinical and clinical pharmacology studies
- Provide strategic guidance to ensure high quality preparation of Regulatory Authority documents i.e. clinical study reports, submissions, clinical protocols and safety reports
- Ensure the accurate communication of clinical trial data internally and to Health Authorities, the academic community, and healthcare providers; ensure that the interpretation of data obtained from trials conducted internally or by collaboration partners, CROs and competitive data is accurate, scientifically sound and credible
- Identify technology needs or other gaps; identify and communicate risks to the business and develop solution-oriented approaches to address or mitigate risk
- Oversee the continued optimization of state-of-the-art, best practice systems for biostatistics, data management and programming while promoting innovation
- Participate in the Development Senior Leadership Team meetings; develop strong and collaborative work relationships with key business stakeholders i.e. Project Team leaders, functional heads within Development, Research and others
- Partners with Medical Affairs and Commercial to provide statistical support for publications
- Mentor and coach direct reports to maximize their potential
Requirements
- PhD in statistics or biostatistics required with minimum of 15 years of experience in the pharmaceutical and/or biotechnology industry
- Management experience with proven capability as a successful leader in a strategic multifunctional environment; highly skilled in leading change
- Strong business acumen and critical thinking skills
- Must possess a comprehensive and detailed understanding of statistical experimental designs and analyses, clinical trial requirements and statistical technical requirements such as SAS, SDTM and CDISC
- Understanding of regulatory guidelines that affect statistical deliverables including ICH, FDA and GCP regulations
- Experience with the management and statistical analysis of data obtained from Phase I-III clinical trials or studies
- Experience in immunology, hematology and or oncology studies preferred
- Experience with PLA/NDA/MAA submissions a must including ISS, ISE development
- Extensive experience negotiating successfully with health authorities
- Strong interpersonal and effective communication (oral and written) skills
- Ability to efficiently manage multiple CROs