Assoc Director or Director, Biostatistics

Associate Director or Director of Biostatistics

Position Summary: 

The Associate Director or Director of Biostatistics will be responsible for providing statistical leadership and strategic partnership in the development of clinical development plans, health authority interactions, research, development science, and manufacturing applications. Their accountabilities typically extend across molecules and disease areas. This role will require both hands-on execution and the technical and strategic acumen to provide expertise to research and development projects.

Essential Duties and Responsibilities:

• Provide statistical leadership for clinical development projects, including strategic input into clinical development plans
• 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
• Ensure study designs are aligned with the project strategy, and statistical methodology is appropriate, sound, and meets scientific and/or regulatory needs
• In collaboration with other functions in Data Science, provide statistical leadership in the development and implementation of data collection instruments to ensure they are designed to capture protocol-specified scientific information and study databases are implemented adequately
• Responsible for the statistical integrity, adequacy, and accuracy of clinical studies
• Provide analytical and strategic leadership for exploratory activities such as personalized healthcare biomarker development
• 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
• Serve as expert statistical consultant for research, development science, and manufacturing applications
• Oversee the deliverables from statistical CROs
• Manage functional contractors or CRO staff, and coaches junior Biostatisticians
• Ensure adherence to business processes and encourages consistent approaches to biostatistics accountabilities
• Contribute to the direction and performance of Biostatistics via mentoring and insights on technical/strategic capabilities
• 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 5 years of biotech or pharmaceutical industry experience as a biostatistician, including experience overseeing statistical group activities
• Experience in oncology clinical trials required, 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 $190,000 to $220,000. 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 will receive an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.