Vice President Biometrics

Vice President Biometrics

Requirements

• Advanced degree (MD, PharmD, PhD) in Biostatistics or a related scientific discipline
• Requires a significant amount of progressively responsible and relevant experience in the biopharmaceutical industry, focusing on clinical research and Biostatistics
• 10 years in a leadership role, which includes leading and managing teams
• Solid knowledge of statistical and SAS programming processes and technologies
• Thorough experience with the drug development process and execution of Biostatics deliverables
• Strong strategic thinking and the ability to consistently demonstrate leadership qualities in a variety of settings
• Capable of managing multiple project responsibilities across a variety of different projects
• Excellent interpersonal communication and networking skills with the ability to build cross-functional bridges
• Highly skilled in delivering Biostats components of clinical projects and regulatory submissions and regulatory interactions
• Ability to accommodate and lead teams through shifting priorities, demands, and timelines
• Ability to elicit cooperation from a wide variety of sources and to be persuasive, encouraging and motivating
• Adept at creating and communicating a clear vision for a program among team members to facilitate the alignment of resources to achieve program and corporate goals
• Must be able to travel both domestically and internationally

Responsibilities

• Oversees advanced biometrical, statistical, and technical activities for analysis and interpretation of statistical data and SAS Programming for Acadia pipeline
• Works closely with Asset and Clinical Lead developing study plans and sign-off of clinical protocols
• Provides strategic thinking and expertise to define the right questions to be answered in the design of clinical trials; specifically contributes from a biostats perspective to the creation of the Clinical Development Plans
• Directs the design, development, modification and evaluation of a technical infrastructure to expedite the management, evaluation and reporting of clinical trials data
• Manages the design, monitors the statistical analysis, and develops tracking systems to determine the efficiency of clinical trials. Manages the evaluation and design of clinical data statistics
• Responsible for leading the Biostats Department teams in ensuring effective, timely, high quality and compliance management and delivery of goals and accountabilities of multiple ongoing projects
• Ensures all department work is performed consistent with Good Clinical Practices (GCP), International Conference on Harmonisation (ICH), 21 CFR part 11, internal SOPs and training, and international regulatory requirements
• Performs other duties as assigned

Preferred Qualifications

No preferred qualifications provided.