Director or Sr Director, Biostatistics

Director or Sr Director of Biostatistics

Position Summary: 

The Director/Senior Director of Biostatistics will be responsible for providing statistical leadership and strategic partnership in the development of clinical development plans, health authority interactions, research, and development science. This role is to serve as a program-level lead statistician and provide statistical leadership for clinical development projects through the product life cycle.

Essential Duties and Responsibilities:

• Provide statistical leadership for clinical development projects, including strategic input into clinical development plans
• Be responsible for the statistical integrity, adequacy, and accuracy of clinical studies
• Ensure study designs are aligned with the project strategy, and statistical methodology is appropriate, sound, and meets scientific and/or regulatory needs
• Be accountable for the statistical input for clinical and regulatory documents for assigned projects, including protocols, statistical analysis plans, clinical study reports, publication and presentations, and others
• Collaborate with other functions to provide statistical leadership in the development and implementation of data collection instruments
• Provides analytical and strategic leadership for exploratory activities such as personalized healthcare biomarker development
• Be the biostatistics lead for Health Authority interactions for assigned projects
• Lead cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation
• Interact with internal and external stakeholders (e.g., vendors, committees) in support of clinical trial objectives
• Serves as expert statistical consultant for research and development science
• Oversee the deliverables from statistical CROs
• Manage functional contractors or CRO staff, and coach junior Biostatisticians
• Ensure adherence to business processes and encourage consistent approaches to biostatistics accountabilities
• Engage in research in statistics to improve drug development methodology consistent with corporate priorities and timeline
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations

Required Education and Experience:

• PhD in Statistics, Biostatistics, Mathematics, or similar areas of academic discipline highly preferred
• At least 6 years (for Ph.D.) or 10 years (for M.S.) of biotech or pharmaceutical industry experience as a biostatistician, including experience overseeing statistical group activities
• Experience in design and analysis of Phase 3 oncology clinical trials desirable, early development experience a plus
• Proficient in SAS, programming in R a plus
• Solid understanding of CDISC models and standards
• Expert knowledge of drug development strategies and regulations, especially those pertinent to statistical analyses
• Demonstrated interest and ability to learn new things; develops solutions to technical problems and drives changes.
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
• Able to work in an entrepreneurial, fast paced, dynamic, team-oriented environment
• Strong oral and written communication skills
• Strong learning orientation, curiosity, and passion for science and patients

The anticipated salary range for this position is $210,000 to $270,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at time of hire and annually in the form of the option to purchase stock in the future for a specified price.