Our commitment to people with muscle diseases is our greatest strength.
Associate Director, Statistical Programming
Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit Dyne Therapeutics.
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 programming and data standards, provides consultation to the program teams, and is 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.
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.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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