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Description
Job DetailsCompany Overview:
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).
Role Summary:
The Senior Vice President (SVP), Head of Data Analytics leads a multidisciplinary team responsible for biostatistics, statistical programming, and data management.
This strategic leadership position requires a broad knowledge of clinical data management, programming and statistical analysis tools to plan studies and interpret results from clinical, modelling and simulation, and epidemiologic studies.
We are seeking a visionary leader with deep expertise in data analytics, a proven track record of driving innovation, and a passion for advancing rare disease research.
We are committed to leveraging cutting-edge science and innovative technologies to accelerate drug discovery and improve patient outcomes. This role plays a pivotal role in driving data-driven decision-making across all stages of drug development.
The SVP, Head of Data Analytics is a subject matter expert concerning global regulatory agencies as well as ICH guidelines and regulations applicable for the conduct, analysis and reporting of clinical trials in rare diseases.
This person provides coaching to team members to enable them to engage in and provide quality input at internal and external meetings including regulatory interactions and meetings with key opinion leaders.
This person is a strong advocate within Dyne for Data Analytics' involvement taking a prominent role in research & development.
Primary Responsibilities include:
Provide strategic direction and leadership for the data analytics function, aligning with corporate goals and objectives
Establish and execute on a strategic roadmap for biostatistics, statistical programming and data management for Dyne as we prepare for commercialization
Serve as the subject matter expert and point person for data analytics for interactions with regulatory agencies, bringing in team members as appropriate
Develop and implement a comprehensive data analytics strategy to support the company's rare muscle disease pipeline
Lead and mentor a high-performing team of biostatisticians, statistical programmers, and clinical data managers
Foster a culture of collaboration, innovation, and continuous learning to drive team success
Provide organizational leadership to balance time, quality, and cost requirements
Strategically set people goals including internal career development and talent management as well as alternative resourcing strategies, where needed
Establish robust data governance processes and standards to ensure the quality, integrity, and security of clinical trial data
Implement best practices for data collection, management, and analysis in compliance with regulatory requirements
Oversee the design and execution of statistical analysis plans for clinical trials, including sample size calculations, randomization schemes, and statistical modeling
Provide strategic input on study design, endpoints, and statistical methodologies
Direct the development and validation of statistical programming code for the analysis and reporting of clinical trial data
Ensure adherence to programming standards, best practices, and global regulatory guidelines
Lead the clinical data management team in the collection, cleaning, and validation of clinical trial data
Implement data management processes and systems to support efficient and accurate data capture and analysis
Collaborate closely with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to support data-driven decision-making
Communicate key findings, insights, and recommendations to senior leadership and external stakeholders
Be accountable for timely, production and accuracy of all statistical analyses and integrated scientific reports for clinical trial results, publications activities, scientific presentation, and regulatory submissions both local and international
Education and Skills Requirements:
Ph.
D. or M.S. in Biostatistics, Statistics, Epidemiology, or related field. Certification in clinical data management (e.g., CDM certification) is a plus
Minimum of 20 years of progressive experience in data analytics, biostatistics, or clinical data management within the pharmaceutical or biotechnology industry including managerial expertise
Prior experience in rare disease drug development is highly desirable
Demonstrated track record of strategic leadership, team management, and organizational development. Proven ability to inspire and motivate teams to achieve excellence
Expertise in statistical analysis methodologies, including clinical trial design, survival analysis, longitudinal data analysis, and Bayesian methods
Proficiency in statistical programming languages (e.g., SAS, R) and clinical data management systems (e.g., Medidata Rave, Oracle Clinical) is essential
In-depth understanding of regulatory requirements and guidelines related to clinical trial design, data collection, and analysis (e.g., FDA, EMA, ICH)
Excellent written and verbal communication skills, with the ability to effectively communicate complex scientific concepts to diverse audiences
Strong interpersonal skills and the ability to collaborate effectively with cross-functional teams in a matrixed environment
#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.
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.
