Principal Statistical Programmer - Massachusetts, United States - Mantell Associates

Description

Mantell Associates is partnered with an organisation searching for a highly skilled and experienced Principal Statistical Programmer to join their biometrics division.

Principal Statistical Programmer - Responsibilities:

• Play a pivotal role in leading statistical programming activities for multiple clinical trials, ensuring the timely and accurate delivery of analysis datasets, tables, listings, and figures
• Collaborate closely with cross-functional teams and clients to support the successful execution of clinical development programs
• Provide leadership and guidance to the statistical programming team, ensuring adherence to industry standards, best practices, and regulatory requirements
• Lead and coordinate statistical programming activities for assigned projects, including timeline management, resource allocation, and deliverable quality assurance
• Develop and validate analysis datasets, statistical tables, listings, and figures in accordance with study protocols, statistical analysis plans, and programming specifications
• Perform comprehensive quality control checks on programmed deliverables to ensure accuracy, consistency, and compliance with regulatory guidelines
• Collaborate effectively with cross-functional teams, including biostatistics, data management, and clinical operations, to address project requirements and resolve programming-related issues
• Identify opportunities for process improvement and optimization in statistical programming activities, driving efficiency and enhancing productivity
• Serve as a primary point of contact for clients on statistical programming matters, providing technical expertise, addressing inquiries, and ensuring client satisfaction
• Provide training, mentorship, and support to junior members of the statistical programming team, fostering their professional growth and development

Principal Statistical Programmer - Requirements:

• Bachelor's or Master's degree in statistics, biostatistics, computer science, or related field
• Minimum of 8 years of experience in statistical programming within the pharmaceutical or biotechnology industry
• Proficiency in SAS programming language, including SAS/Base, SAS/STAT, SAS/MACRO, and SAS/GRAPH
• Strong understanding of clinical trial data structures, CDISC standards, and regulatory requirements (e.g., FDA, EMA, ICH)
• Excellent leadership, project management, and communication skills
• Proven ability to work effectively in a dynamic, fast-paced environment and manage multiple priorities simultaneously
• Experience with programming in R or other statistical software packages is a plus
• Familiarity with version control systems (e.g., Git) and programming languages such as Python is desirable

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at