Responsible for overseeing the design, execution and interpretation of statistical analyses for clinical trials focused on rare disease. Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management. Provide statistical expertise and strategic guidance to ensure successful development and regulatory approval of novel therapies.

Primary Responsibilities

• Leads the design and planning of statistical methodologies for clinical trials including:

• • Sample size and power calculations
  • Randomization
  • Data collection strategies/CRF review
  • Review and/ or development of protocol, statistical analysis plan and other related study documents
  • Consideration of unique characteristics of rare diseases and specific regulatory requirements
• Oversees implementation of statistical analyses, including data monitoring, programming and complex modeling
• Summarizes and interprets results and provides meaningful insights for decision making, risk assessment and regulatory submissions
• Maintain thorough understanding of current regulatory guidelines and requirements relevant to rare disease drug development
• Collaborates closely and effectively with R&D teams as well as external partners throughout the drug development process
• Stay current with advancements in statistical methodologies and rare disease research. Applies sound and innovative statistical methods to various study designs to drive continuous improvement in clinical trial practice
• Provides oversight and management of internal and/or external statistical staff and assists in planning of resources
• Develops and assists in maintenance of department tools, templates, guidelines, SOPs, and systems
• Provides statistical input into other disciplines' activities and participates in interdepartmental processes
• Other duties as assigned

Education/Experience/Skills

Ph.D. in Statistics, Biostatistics or a related field. Targeting 10 years of experience as lead statistician on clinical trials in the pharmaceutical industry with significant experience in rare disease drug development. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Solid knowledge of Statistical Analysis System (SAS) programming and knowledge of statistical software (e.g., R, S-Plus, nQuery, EAST). Experience in programming complex statistical analyses
• Extensive working knowledge of FDA regulations, ICH GCP guidelines, and the drug development process. Prior regulatory experience with rare disease drug approval is preferred
• Strong knowledge of statistical methodologies and clinical trial design, experience with adaptive trial design and Bayesian methodologies is a plus
• Solid command of the English language and excellent verbal and written communication skills and skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization
• Ability to consistently demonstrate leadership qualities and ability to manage project responsibilities independently across a variety of different projects; objectively evaluate situations and make recommendations to meet project goals
• Excellent interpersonal and networking skills with the ability to build cross functional relationships
• Prior CRO/statistical team management experience

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.

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