Director, Statistical Programming

Role Summary

The Director, Statistical Programming is accountable for in-house statistical programming activities and oversight of related activities by vendors for assigned clinical development programs. In collaboration with functional line management and cross functional stakeholders, this position contributes to the process optimization and innovation for clinical development. This position serves as an in-house expert for statistical programing and data standards, and assists the team to develop functional strategies and drives the development and continuous improvement of departmental procedures, training and standards.

Responsibilities

• Lead and manage the statistical programming activities for clinical trials and studies, ensuring high-quality deliverables and adherence to timelines
• Collaborate with biostatisticians, data managers, and cross-functional teams to define programming strategies and requirements
• Develop, validate, and maintain analysis datasets (CDISC standards), tables, listings, and figures, TLFs) in accordance with regulatory guidelines and internal standards
• Review statistical analysis plans (SAPs) to provide feedback and strategy to the team to execute the plans
• Perform complex statistical analyses and simulations using SAS, and R, to support clinical trial design and data interpretation
• Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD)
• Build and maintain software agnostic solutions/macros to automate repetitive tasks.
• Provide novel solutions to the Biometrics and cross-functional teams to better understand the data
• Manage, mentor and provide guidance to junior programmers, ensuring their growth and development within the team
• Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis

Education

• MS or BS degree in Statistics, Computer Science, Mathematics, Public Health, or related quantitative fields.

Qualifications

• MS with a minimum of 12 years or BS with a minimum of 14 years of experience in a pharmaceutical industry or other clinical research setting with clinical trials; direct supervisory experience preferred
• Highly competent in SAS programming and Macro development; ability to understand the implementation of statistical analyses
• Preferred knowledge of other programming languages such as R
• Thorough understanding of ICH Guidelines and relevant regulatory requirements and CDISC standards
• Familiarity with expectations of regulatory agencies, like FDA, EMA etc.
• Direct experience with NDA/BLA or other regulatory filing, including ISS or ISE.
• Experience with departmental resource allocation and labor requirement assessment
• Excellent written, verbal, and interpersonal communication skills, and strong negotiation, and organizational skills
• Ability to work effectively and efficiently independently and as part of a functional and cross-functional team
• Ability to influence without authority
• Willing and able to demonstrate agility and flexibility as needed in a small biotech
• Ability to work effectively in a highly dynamic and fast-moving environment
• Awareness to escalate issues appropriately