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Director, Clinical Data Management & Data Science
$196,000 - $216,000 / year
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Job Description
- Unique Growth Opportunity: Gain hands-on experience across clinical studies, data analysis, regulatory submissions, and product development.
- Data-Driven Innovation: Work alongside experienced leaders, contributing to real-world healthcare solutions backed by rigorous data.
- Fast-Paced Start-Up Culture: Be part of an agile, mission-driven team where your work has immediate impact.
- Professional Development: Receive mentorship and opportunities to expand your technical and industry knowledge.
- Meaningful Impact: Help bring innovative diagnostic products to market that can improve patient outcomes.
- You love and thrive in a fast-paced and dynamic environment where you can implement fresh ideas, new processes, and make things happen quickly without a bunch of red tape
- You’ll have great perks such as:
- Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K),
- Flexible vacation
- Kombucha and cold brew on tap, craft coffee, and a variety of healthy snacks
- Develop and execute a unified, robust, and scalable data strategy to support clinical trials, R&D studies, and regulatory submissions.
- Build and mentor a high-performing team of data managers, database programmers, biostatisticians, and data scientists.
- Serve as a senior advisor to Clinical, R&D, and Regulatory leaders on data architecture, analytics, and evidence strategies.
- Ensure alignment of data architecture with business goals and regulatory requirements.
- Data Infrastructure and Systems Development
- Lead the design, integration, and governance of clinical databases and data pipelines from the ground up.
- Oversee implementation and validation of EDC systems, LIMS, and data warehouse tools to harmonize internal and CRO data sources.
- Guide the creation of user-friendly tools for data input, extraction, and analysis across teams.
- Ensure compliance with 21 CFR Part 11, GCP, HIPAA, and other applicable data regulations. Hire, mentor, and manage a team of data professionals to support clinical and R&D initiatives.
- Establish SOPs, standards, and templates for data collection, cleaning, reconciliation, and database lock.
- Direct data management activities for clinical studies, ensuring data quality, completeness, and traceability.
- Collaborate with CRO partners and central labs to ensure consistent data flow and integrity.
- Biostatistics & Data Science
- Provide strategic direction for statistical design, analysis, and interpretation of clinical and analytical validation studies.
- Oversee development of statistical analysis plans (SAPs) and ensure robustness of models and results.
- Guide exploratory and confirmatory data analyses, leveraging both traditional biostatistics and modern data science/ML techniques.
- Drive the development of data visualization dashboards and analytic tools to support real-time decision-making.
- Partner with Clinical Operations, Regulatory Affairs, Quality, and Product Development teams to ensure alignment of data strategy with business goals.
- Support regulatory submissions (FDA, IVDR) through clear, validated, and reproducible data outputs.
- Translate complex data analyses into compelling, clear narratives for scientific and regulatory audiences.
- Master’s or PhD in Biostatistics, Data Science, Biomedical Informatics, or related quantitative field.
- Minimum of 10 years of experience in clinical data management, biostatistics, or data science roles within diagnostics, medical devices, or pharmaceuticals
- Minimum of 5 years of management and leadership experience
- Proven experience building and leading data teams (data management, biostatistics, and informatics) from the ground up in a regulated environment.
- Demonstrated ability to design and integrate clinical databases and data pipelines across multiple systems and vendors.
- Strong command of SQL and relational databases (e.g., PostgreSQL, MS SQL Server).
- Deep understanding of FDA regulations, including 21 CFR Part 11, Part 820, GCP, ICH E6, and regulatory requirements for IVD data.
- Familiarity with EDC systems (Medidata, REDCap, etc.), data visualization tools (Tableau, Spotfire, Power BI), and data standards (CDISC/SDTM, HL7/FHIR).
- An analytical mindset with strong attention to detail and the ability to draw meaningful insights from complex datasets.
- Proactive, self-motivated, and eager to take ownership of tasks and learning opportunities.
- Exceptional communication skills and ability to translate complex statistical concepts and data into clear, actionable insights for technical and non-technical audiences.
- Comfortable working in a fast-paced, start-up environment with shifting priorities.
- Knowledge of cloud platforms (AWS, Azure) and data governance frameworks.
- Startup or small-company experience building infrastructure from scratch
- Prior experience supporting FDA submission data requirements for IVDs (e.g., 510(k), PMA, EUA).
- $196,000 - $216,000
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