Associate Director, Clinical Data Analyst
2 months ago
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 Associate Director, 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 by wrangling data (files based, database, and large datasets), applying advanced analytics methodology (statistics, AI/ML models) and creating informative data visualizations, employing data storytelling, data, analytics, and narratives to develop compelling insights that drive measurable and actionable change.
This is a full-time position based in Waltham, MA without the possibility of being 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 (data wrangling) of both operational and collected data, structured and unstructured, for downstream analysis and reporting Apply advanced analytics (methods and tools) to identify trends and develop predictive models for events and behaviors Support and develop clinical data analyses (TLFs, 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 dataEducation and Skill Requirements:
8+ years’ relevant experience in healthcare (medical, biopharmaceutical) data analytics and related technologies Bachelor’s degree in Computer Science, Applied Mathematics/ Data Sciences/ Data Analytics or related discipline required, advanced degree preferred Experience with large datasets, designing and developing pipelines and analyses (TLFs, visualizations), ideally with clinical or research data sources Experience with analytic methods and technologies (artificial intelligence, machine learning/ deep learning/ neural networks, natural language processing, visualizations) Demonstrated proficiency with data science languages (R, Python, SQL, Julia, SAS) and visualization tools (Tableau, Spotfire, SAS, JMP, RShiny) Experience presenting statistical methods and concepts to non-mathematically inclined stakeholders to gain trust and drive additional data insight 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
#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.
-
Associate Director, Clinical Data Analyst
4 months ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany 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 FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
-
Manager, Clinical Data Management
2 months ago
Waltham, United States Statistics & Data Corporation (SDC) Full timeJob DescriptionJob DescriptionManager, Clinical Data ManagementSDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team...
-
Associate Director, Clinical Scientist
2 weeks ago
Waltham, United States Deciphera Pharmaceuticals Full timeJob DescriptionJob DescriptionCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of...
-
Associate Director, Clinical Operations
1 month ago
Waltham, United States Deciphera Pharmaceuticals, Inc Full timeDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch–control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.Enabled by our proprietary...
-
Associate Director, Clinical Operations
1 month ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals, Inc Full timeDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch–control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.Enabled by our proprietary...
-
Waltham, Massachusetts, United States Alkermes, Inc. Full timeJob SummaryThis is a leadership position responsible for Clinical Programming efforts in Data Management & Programming department and Clinical Development Operations organization.Key ResponsibilitiesLeadership and Team Management: Provide leadership and oversight to internal clinical programming, SDTM conversions, and ad-hoc requests for Alkermes clinical...
-
Clinical Research Director
4 days ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob DescriptionDeciphera Pharmaceuticals is a biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines to improve the lives of people with cancer. We leverage our proprietary switch-control kinase inhibitor platform and expertise in kinase biology to develop a diverse portfolio of medicines.We are seeking an...
-
Data Analyst
2 months ago
Waltham, United States Scipher Medicine Full timeAbout Us: Scipher Medicine is a precision immunology company that uses AI and network science to match patients with the most effective therapies. Its flagship product, PrismRA, is a blood-based test that predicts whether a patient with RA is likely to respond to anti-TNF therapy. Scipher Medicine is also developing the Spectra platform, which can be used to...
-
Data Analyst
2 months ago
Waltham, United States Scipher Medicine Full timeAbout Us: Scipher Medicine is a precision immunology company that uses AI and network science to match patients with the most effective therapies. Its flagship product, PrismRA, is a blood-based test that predicts whether a patient with RA is likely to respond to anti-TNF therapy. Scipher Medicine is also developing the Spectra platform, which can be used to...
-
Data Analyst
1 day ago
Waltham, Massachusetts, United States LLX Solutions Full timeJob Title: StatisticianWe are seeking a highly skilled Biostatistician to join our team at LLX Solutions.Position Overview:The Biostatistician will be responsible for reviewing protocols and case report forms, performing sample size calculations, writing Statistical Analysis Plans, developing and producing interim and final reports.This position will also...
-
Associate Director, Clinical Operations
1 month ago
Waltham, United States Deciphera Pharmaceuticals Full timeJob DescriptionJob DescriptionCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of...
-
Associate Director, Clinical Operations
1 week ago
Waltham, United States Deciphera Pharmaceuticals Full timeJob DescriptionJob DescriptionCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of...
-
Waltham, Massachusetts, United States CSL Behring Full timeAbout the RoleCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. Our company is committed to delivering medicines that improve their lives.We are seeking an experienced Associate Director Clinical Portfolio Execution to join our...
-
Pathologist, Associate Director or Director
1 month ago
Waltham, United States National Black MBA Association Full timePathologist, Associate Director or Director – Oncology Safety Pathology, Clinical Pharmacology and Safety SciencesAre you ready to make a significant impact in the field of oncology safety pathology? We are seeking a passionate veterinary anatomic pathologist to join our global team of experts. This role offers a unique opportunity to collaborate with...
-
Quantitative Clinical Pharmacologist
6 days ago
Waltham, Massachusetts, United States GlaxoSmithKline Full timeJob SummaryWe are seeking a highly motivated and experienced Quantitative Clinical Pharmacologist to join our team as a Manager or Associate Director in the Clinical Pharmacology Modelling and Simulation (CPMS) department. As a key member of our team, you will be responsible for delivering clinical pharmacology and modelling & simulation excellence to...
-
Waltham, United States Dyne Therapeutics Full timeCompany 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...
-
Clinical Data Specialist
2 weeks ago
Waltham, Massachusetts, United States LLX Solutions Full timeLLX Solutions is seeking a highly motivated and detail-oriented Clinical Data Programmer to join our growing team. In this role, you will play a crucial part in ensuring the accuracy and integrity of clinical data used for research and development purposes. You will collaborate closely with data managers and other stakeholders to support all phases of...
-
Associate Director, Statistical Programming
2 months ago
Waltham, United States Dyne Therapeutics Full timeCompany 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...
-
Waltham, United States Leading Age Full timePosition SummaryUpstream Bio is developing innovative therapeutics to treat inflammation. We are a nimble company with solid financial backing from high–quality investors. We have a clinical stage asset, verekitug, a fully human monoclonal antibody, with proof of concept in inflammation and plans to expand into other therapeutic areas. Our offices are in...
-
Waltham, United States Dyne Therapeutics Full timeCompany 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...
