Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
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.
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
- 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 and Skills Requirements:
- MS or BS degree in Statistics, Computer Science, Mathematics, Public Health, or related quantitative fields.
- 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
#LI-Onsite
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
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.
Top Skills
What We Do
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 seen with other approaches. Dyne has a broad portfolio of programs for serious muscle diseases, including candidates for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com.
