Dyne Therapeutics
AssociateDirector,StatisticalProgramming
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“Associate Director, Statistical Programming at Dyne Therapeutics. Skills: Statistical programming, CDISC standards, Regulatory submissions. Lead statistical programming activities. Oversee vendor programming activities”
Industry & Context.
Root cause analysis
What They're Looking For.
Must Have
10 years statistical programming experience, Bachelor's degree, SAS proficiency, CDISC standards knowledge, Regulatory submission experience
Nice to Have
Advanced degree preferred, R experience preferred, Python experience preferred, Vendor programming experience preferred
What You'll Do.
Lead statistical programming activities
Oversee vendor programming activities
Contribute to process optimization
Provide technical leadership
Support alignment of resources
Assist in departmental strategies
Drive continuous improvement
Develop analysis datasets
Validate analysis datasets
Review analysis datasets
Maintain analysis datasets
Provide technical consultation
Perform statistical analyses
Support advanced analytical solutions
Support data visualization solutions
Provide expertise for regulatory submissions
Oversee submission readiness activities
Coordinate vendor activities
Oversee vendor activities
Maintain reusable tools
Promote reusable tools
Build automation solutions
Maintain automation solutions
Promote automation solutions
Contribute to programming standards
Contribute to programming processes
Contribute to validation practices
Contribute to innovation initiatives
Mentor junior programmers
Provide technical guidance
Supervise programming teams
Lead programming teams
Supervise contractors
Support resource planning
Support prioritization
Support coordination of deliverables
How You'll Work.
Team & Collaboration
Cross-functional stakeholders; Cross-functional teams; Biostatisticians; Data managers; Clinical operations; Vendors
Process & Methodology
Project management
Full Job Description
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. 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 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. Role Summary: The Associate Director, Statistical Programming is accountable for program-specific and cross-study statistical programming activities, including oversight of vendor programming activities. In collaboration with cross-functional stakeholders, this position contributes to process optimization, innovation, and consistency across studies. This position provides technical leadership for statistical programming activities across multiple studies within a program, including oversight of vendor-related activities and implementation of data standards. In collaboration with cross-functional stakeholders, this role provides technical consultation to study teams and supports alignment of statistical programming
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