Associate Director, Statistical Programming

Role Summary:

The Associate Director, Statistical Programming is accountable for program specific statistical programming activities and oversight related activities by vendors in clinical development, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverables. In collaboration with cross functional stakeholders, this position contributes to process optimization and innovation for clinical development. This position serves as the program team point person for statistical programing and data standards, provide consultation to the program teams, and be responsible for building a statistical programming team to support the Dyne clinical portfolio. This role assists the Head of Statistical Programming to contribute to departmental strategies and helps to drive the development and continuous improvement of departmental procedures, training, and standards.

This is a full-time position based in Waltham, MA without the possibility of being remote

Primary Responsibilities Include:

• 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
• 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 and Skills Requirements:

• Bachelor's or advanced degree in statistics, biostatistics, computer science, or a related field
• Minimum of 8 years of experience in statistical programming within the pharmaceutical or biotech industry
• Proficiency in SAS and R is essential; experience with Python is desirable
• Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements for clinical trials
• Demonstrated leadership and project management skills, including the ability to lead cross-functional teams
• Excellent communication and interpersonal skills
• Detail-oriented with a commitment to data accuracy and quality
• Ability to adapt to changing priorities and manage multiple projects simultaneously

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