Senior Clinical Scientist

United States Digital Space LLC

Boston (MA)

On-site

USD 145,000 - 195,000

Full time

5 days ago
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Job summary

United States Digital Space LLC is seeking a Senior Clinical Scientist to independently own assigned clinical studies, translating questions into rigorous research across wearable and real-world data.

You will lead study design, analysis, literature integration, and regulatory communications, partnering across product, data science, and regulatory teams to drive evidence generation and product decisions.

Qualifications

  • Advanced degree preferred in Life Sciences or related field.
  • 6-9 years in clinical research, data analysis or real-world evidence settings.
  • Experience leading clinical studies and reporting.

Responsibilities

  • Independently design and lead clinical study protocols and analysis plans.
  • Oversee study execution including startup, data collection, monitoring, and closeout.
  • Use statistical tools to analyze datasets and generate actionable insights.

Skills

R
SAS
Python
Stata

Education

Advanced degree in Life Sciences/Clinical Research/Public Health/Epidemiology/Biostatistics/Medicine or related

Tools

Statistical software

Job description

the company is an advanced health and fitness wearable on a mission to unlock human performance. We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives.

As a Senior Clinical Scientist, you will independently own assigned clinical studies that support the company’s clinical development, product innovation, and regulatory objectives. Operating with minimal oversight, you will translate clinical and product questions into rigorous research approaches, generate and interpret evidence from clinical, wearable, and real-world data, and communicate findings in a way that informs product decisions, regulatory strategy, and clinical evidence generation. This role requires someone who can lead their assigned workstreams, partner effectively across cross-functional teams.

RESPONSIBILITIES
  • Independently lead the design and development of clinical study protocols, evidence-generation plans, endpoints, study procedures, and statistical analysis approaches with minimal oversight. Ensure studies are scientifically rigorous and aligned with clinical, product, and regulatory objectives
  • Support and oversee key aspects of study execution, including feasibility assessment, study startup, data collection, data review, monitoring oversight, and study closeout. Partner with Clinical Operations, Data Management, and external vendors or sites as needed to ensure high-quality execution
  • Use statistical tools such as R, SAS, Python, Stata, or similar platforms to analyze clinical, wearable, and real-world datasets. Interpret results, identify trends and limitations, and generate actionable insights that support clinical, regulatory, and product decision-making
  • Conduct comprehensive literature reviews to inform study design, endpoint selection, statistical methodologies, product claims, regulatory strategy, and scientific positioning. Integrate external scientific evidence with the company data to support clinical development goals
  • Ensure the accuracy, integrity, and quality of clinical data by implementing and reviewing appropriate quality control measures throughout the study lifecycle. Conduct quality checks on datasets, statistical outputs, tables, figures, listings, and scientific conclusions
  • Communicate complex clinical and statistical findings in clear, actionable terms to clinical, product, data science, regulatory, and executive stakeholders. Translate technical analyses into meaningful business, product, and clinical insights
  • Independently author and review clinical study reports, protocols, statistical analysis plans, literature reviews, clinical evidence summaries, regulatory submission sections, manuscripts, abstracts, and internal scientific memos. Ensure documentation is accurate, scientifically sound, and regulatory-compliant
  • Work closely with Product, Data Science, Engineering, Clinical Operations, Regulatory Affairs, Quality, and Legal teams to ensure clinical and scientific input is incorporated throughout the product lifecycle
  • Contribute to evidence-generation strategies and clinical documentation for regulatory submissions, including 510(k), De Novo, CE Mark, clinical evaluation reports, clinical study reports, and responses to regulatory questions
  • Lead or contribute to manuscripts, abstracts, posters, presentations, and other scientific communications for internal stakeholders, scientific conferences, peer-reviewed journals, and external collaborators
QUALIFICATIONS
  • Advanced degree preferred in Life Sciences, Clinical Research, Public Health, Epidemiology, Biostatistics, Biomedical Engineering, Medicine, or a related field. Master’s, PhD, MD, PharmD, MPH, or equivalent experience strongly preferred
  • 6-9 years of experience in clinical research, clinical science, data analysis, epidemiology, medical device, digital health, SaMD, pharmaceutical, biotech, or real-world evidence settings
  • Demonstrated ability to independently design and lead clinical studies, including protocol development, endpoint selection, study methodology, statistical analysis planning, and clinical study report writing
  • Strong understanding of FDA regulations, ICH-GCP, ISO 14155, clinical trial design, and evidence-generation requirements for regulated or health-related products
  • Experience contributing to regulatory submissions or clinical evidence packages, such as 510(k), De Novo, CE Mark, clinical evaluation reports, clinical study reports, or related documentation
  • Proficiency in statistical software such as R, SAS, Python, Stata, or similar tools
  • Strong analytical and problem-solving skills, with the ability to interpret complex datasets and clearly explain findings, limitations, and implications
  • Excellent written and verbal communication skills, including experience writing clinical study reports, regulatory documents, scientific manuscripts, abstracts, presentations, or internal research summaries
  • Ability to independently manage complex workstreams, prioritize effectively, and deliver high-quality work in a fast-paced environment with minimal oversight
  • Nice to have: Experience working with clinical data, wearable data, real-world data, observational datasets, or large-scale health datasets
  • Nice to have: Experience with software as a medical device, digital biomarkers, wearable sensors, remote patient monitoring, or consumer health technology
  • Nice to have: Experience with Snowflake or other large-scale data platforms
  • Nice to have: Familiarity with software validation, algorithm validation, and clinical performance evaluation for digital health or SaMD products

This role is based in the the company office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.

the company is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

The the company compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values.

At the company, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of the company and share in the company’s long-term growth and success.

The U.S. base salary range for this full-time position is $145,000 - $195,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training.

In addition to the base salary, the successful candidate will also receive benefits and a generous equity package.

These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate’s specific qualifications, expertise, and alignment with the role’s requirements.

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