Clinical Programming Director

Who We Are:

Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click’s treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click’s platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn. 

About the Role:

The Clinical Programming Director reports directly to the Senior Director, Biometrics. This is a hands-on role and will be pivotal in executing and supporting the analysis and reporting of clinical trial data, ensuring the highest quality and compliance with industry standards, and will play a critical part in designing, developing, and maintaining our clinical data infrastructure. The ideal candidate will have a proven track record of success in clinical programming, strong technical skills, and excellent communication and collaboration abilities.

This position can be based out of Click’s headquarters located in Tribeca, NYC, at the center of one of the fastest-growing digital health communities or at one of our industrious offices in Boston, MA, Miami, FL or Raleigh, NC. We have a hybrid working model that consists of at least 3 days in office each week.

Responsibilities:

• Develop and implement the clinical programming strategy to align with overall clinical development plans.
• Contribute to the development and review of clinical study protocols, statistical analysis plans (SAPs), and other study-related documents.
• Develop, validate, and maintain programs for the analysis and reporting of clinical trial data (tables, listings, figures).
• Integrate clinical data from various sources for data storage and efficient data access and analysis.
• Collaborate with Data Managers to develop and implement data quality checks and validation processes to ensure the accuracy, integrity, and reliability of clinical data.
• Prepare data for statistical analysis, generating reports and visualizations.
• Ensure adherence to Good Clinical Programming Practices (GCPP), industry standards, and regulatory guidelines (e.g., ICH, FDA, EMA)
• Collaborate effectively with cross-functional teams, including statisticians, data managers, and medical writers.
• Leverage your expertise in data engineering principles and best practices to create a robust and secure clinical data environment.
• Stay up-to-date with industry trends and advancements 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 the pharmaceutical or biotechnology industry.
• 5+ years of experience in a leadership or management role, overseeing clinical programming teams.
• Expert knowledge of statistical software packages (e.g., SAS, R, Python).
• Strong understanding of CDISC standards (SDTM, ADaM) and regulatory requirements.
• Knowledge of clinical trial design and statistical analysis.
• Experience with electronic data capture (EDC) systems and data management processes.
• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills, with the ability to work effectively in a team environment.

Compensation:

The base salary range for this