Click Therapeutics develops FDA-regulated prescription digital therapeutics software for unmet medical needs, delivering treatments via smartphones.

Click Therapeutics is at the forefront of digital therapeutics innovation, developing FDA-regulated prescription treatments delivered through smartphones. As a Senior Specialist, DTx Quality Engineer, you'll play a crucial role in developing Software as Medical Device (SaMD) products.

The position involves working closely with Product Management, Software Engineering, and Testing teams to drive product quality activities and implement Quality Management System procedures in alignment with FDA and international medical device regulations. You'll report to the Senior Manager of DTx Quality Engineering and directly impact bringing medical device software to market.

This contract position offers the opportunity to work with cutting-edge digital therapeutics addressing various medical needs across psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. You'll be responsible for implementing software development lifecycle processes, cybersecurity measures, and risk management for multiple ex-US SaMD products.

The role requires expertise in international medical device regulations and standards, including UK Medical Device Regulation, EU MDR, and ISO 13485. You'll prepare design control deliverables, coordinate with ex-US quality and regulatory roles, and manage regulatory submissions.

Click Therapeutics offers a collaborative environment consistently rated as a best place to work, bringing together innovators, clinicians, scientists, researchers, and engineers. The position provides competitive hourly compensation and flexible equipment choice.

Join a company committed to making a difference in healthcare through digital therapeutics, working alongside diverse professionals united in the mission to provide accessible, effective prescription digital treatments to patients worldwide.

Senior DTx Quality Engineer position at Click Therapeutics, leading quality management for digital therapeutic medical devices.

Senior Specialist, DTx Quality Engineer

Click Therapeutics develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs.

Click Therapeutics is seeking a Clinical Programmer to join their team. This role reports directly to the Senior Director, Biometrics and is pivotal in executing and supporting the analysis and reporting of clinical trial data. The ideal candidate will have a proven track record in clinical programming, strong technical skills, and excellent communication abilities.

Key Responsibilities:
- Develop and implement clinical programming strategies
- Contribute to clinical study protocols and statistical analysis plans
- Develop, validate, and maintain programs for clinical trial data analysis
- Integrate clinical data from Snowflake into various sources
- Collaborate with Data Managers on data quality checks and validation
- Prepare data for statistical analysis and generate reports
- Ensure adherence to industry standards and regulatory guidelines
- Collaborate with cross-functional teams
- Stay updated on industry trends in clinical programming

Qualifications:
- Bachelor's or Master's degree in Computer Science, Statistics, or related field
- 10+ years of experience in clinical programming within pharma/biotech
- 5+ years in a leadership role overseeing clinical programming teams
- Expert knowledge of statistical software (SAS, R, Python)
- Strong understanding of CDISC standards and regulatory requirements
- Experience with EDC systems and data management processes
- Excellent problem-solving and analytical skills

This position offers a competitive salary range of $130,000 - $150,000, along with performance-based bonuses, equity, and comprehensive benefits. The role can be based in New York City, Boston, Miami, or Raleigh, with a hybrid working model requiring at least 3 days in the office each week.

Click Therapeutics is an equal opportunity employer committed to fostering a diverse and inclusive workplace. They offer a range of benefits including health insurance, unlimited PTO, 401(k) matching, and professional development opportunities.

Senior Clinical Programmer role at Click Therapeutics, developing and analyzing clinical trial data with 10+ years experience required.

Click Therapeutics Engineering Jobs

Click Therapeutics develops FDA-regulated prescription digital therapeutics software for unmet medical needs, delivering treatments via smartphones.