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Senior Manager, Clinical Data Analyst

Waltham, MA

Company 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). For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook. 

Role Summary:

The Senior Manager, Clinical Data Analyst, has a critical role in the delivery of high-quality external data across Dyne’s development pipeline by proactively identifying, measuring, and mitigating risk prior to acquisition of non-electronic data capture (EDC) data. The Clinical Data Analyst partners cross functionally to identify risk to data integrity throughout the data flow to drive quality collection for non-EDC data sources (fluid & tissue labs, digital, imaging, wearables) in Dyne’s clinical studies. This role works with internal stakeholders and external vendors to define the data flow from collection at site or remotely through integration with the clinical database, for analysis and reporting.  The role coordinates cross-functionally to design and produce reports and visualizations, both through programming and data platforms, to mitigate the identified risks, merging with EDC collected data as needed. Analysis will be developed through programming listings and creating informative data visualizations to drive measurable and actionable change.

This is a full-time position based in Waltham, MA without the possibility of being fully remote.

Primary Responsibilities Include:

  • Coordinate with data management study leads, clinical operations, internal stakeholders and external vendors to map non-EDC data from collection through analysis
  • Partner with IT, internal functions and external vendors to develop secure data transfer pipelines for non-EDC data sources
  • Participate in developing and applying clinical data standards to drive quality non-EDC data collections across programs
  • Participate in cross-functional efforts to identify risks to data integrity and quality for external data sources
  • Develop automated means of measuring and mitigating risk through quantitative analysis of operational and collected data
  • Proactively problem solve, formulate problem statements and sets, derive them to manageable data collections and apply critical thinking to develop solutions
  • Develop technical standards for the organization and storage of both operational and collected data, structured and unstructured, for downstream analysis and reporting
  • Support and develop clinical data analyses (, visualizations) for the review of both non-EDC and EDC sourced data
  • Participate in and effectively deliver periodic reviews of quantitative analyses to stakeholders, to drive process and collection optimization
  • Provide input to and assist with the development and implementation of cross-functional standards and processes for external data

 

Education and Skills Requirements:

  • Minimum 6 years’ relevant experience in healthcare (medical, biopharmaceutical) data analytics and related technologies, and Bachelor’s degree in Computer Science, Applied Mathematics/ Data Sciences/ Data Analytics or related discipline required, or 4+ years relevant experience and advanced degree
  • Experience with large datasets, designing and developing pipelines and analyses (TLFs, visualizations), ideally with clinical or research data sources
  • Demonstrated proficiency with programming languages (including but not limited to R, Python, SQL, Julia, SAS) and visualization tools (including but not limited to Tableau, Spotfire, SAS, JMP, RShiny)
  • Experience with data infrastructure and analysis platforms, elluminate preferred
  • Experience with clinical trial data
  • Experience working in an outsourced data management model preferred
  • Experience in rare disease is preferred
  • Knowledge of and experience with medical terminology, controlled terminology, clinical data standards is a plus
  • Ability to successfully contribute to improving the quality of internal data management policies, programs and initiatives
  • Excellent interpersonal skills and communication skills (verbal and written) with the ability to work independently and collaboratively in a dynamic team environment
  • Experience presenting to senior management and program teams
  • Ability to thrive working in a fast-paced environment, manage a variety of projects simultaneously, and handle rapidly changing information
  • Ability to clearly communicate, resolve complex issues, and mitigate risks

 

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.

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