Senior Manager, Statistical Programming
Location: Waltham, MA
Department: 1220GL - Data Analytics
Company Overview:
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 Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a 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 at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
The Senior Manager, Statistical Programming serves as the statistical programming lead for a defined number of clinical studies, with accountability for all study-level statistical programming activities conducted in-house and/or through vendor oversight. This role is the primary point of contact for statistical programming and data standards for assigned studies, providing technical leadership and consultation to cross-functional program teams. The Senior Manager also supports the planning and resourcing of statistical programming activities to ensure timely and high-quality delivery across the Dyne clinical portfolio. This position contributes to departmental strategy, as well as the development and continuous improvement of programming procedures, training, and standards.
This is a full-time position based in Waltham, MA.
Primary Responsibilities Include:
- Lead statistical programming for assigned clinical studies, with end-to-end accountability for study-level programming deliverables, quality, timelines, and compliance with regulatory requirements and internal standards
- Oversee and coordinate FSP vendor-based statistical programming resources, including task assignments, progress tracking, issue escalation, and quality oversight
- Plan, manage, and monitor project timelines and deliverables across assigned studies to ensure on-time and high-quality execution in alignment with study milestones and escalate risks as appropriate
- Collaborate closely with biostatisticians, data managers, and cross-functional teams to define and execute effective programming activities and study-specific requirements
- Develop, validate, and maintain analysis datasets (CDISC-compliant SDTM and ADaM), as well as tables, listings, and figures (TLFs), in accordance with regulatory guidelines and internal standards
- Review and provide input on Statistical Analysis Plans (SAPs) to ensure programming assumptions, derivations, and outputs are clearly defined and executable
- Perform or oversee complex statistical programming and analyses using SAS to support clinical trial analyses and data interpretation
- Provide statistical programming expertise to oversee and/or perform activities supporting regulatory submissions (e.g., FDA, EMA), including the preparation of electronic submission components (eCTD), Define.xml, and reviewer guides
- Stay current with industry trends, best practices, and emerging technologies in statistical programming, data standards, and regulatory expectations
Education, Experience, and Skills Requirements:
- Bachelor's or advanced degree in statistics, biostatistics, computer science, or a related field
- 7+ years of experience in statistical programming within the pharmaceutical or biotech industry
- Proficiency in SAS is essential; experience with R is preferrable
- Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements for clinical trials
- Demonstrated leadership and project management skills, including the ability to collaborate with cross-functional teams
- Excellent written and verbal 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
The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.
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.
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.
There are more than 50,000 engineering jobs:
Subscribe to membership and unlock all jobs
Engineering Jobs
60,000+ jobs from 4,500+ well-funded companies
Updated Daily
New jobs are added every day as companies post them
Refined Search
Use filters like skill, location, etc to narrow results
Become a member
🥳🥳🥳 452 happy customers and counting...
Overall, over 80% of customers chose to renew their subscriptions after the initial sign-up.
To try it out
For active job seekers
For those who are passive looking
Cancel anytime
Frequently Asked Questions
- We prioritize job seekers as our customers, unlike bigger job sites, by charging a small fee to provide them with curated access to the best companies and up-to-date jobs. This focus allows us to deliver a more personalized and effective job search experience.
- We've got over 200,000 jobs from 15,000+ vetted companies. No fake or sleazy jobs here!
- We aggregate jobs from 15,000+ companies' career pages, so you can be sure that you're getting the most up-to-date and relevant jobs.
- We're the only job board *for* software engineers, *by* software engineers… in case you needed a reminder! We add thousands of new jobs daily and offer powerful search filters just for you. 🛠️
- Every single hour! We add 2,000-3,000 new jobs daily, so you'll always have fresh opportunities. 🚀
- Typically, job searches take 3-6 months. EchoJobs helps you spend more time applying and less time hunting. 🎯
- Check daily! We're always updating with new jobs. Set up job alerts for even quicker access. 📅
What Fellow Engineers Say