Clinical Data Scientist

Cyllene Therapeutics is a clinical-stage biotechnology company developing next-generation DNA medicines for the treatment of prevalent chronic and severe neurological disorders. We have developed our proprietary HERMES (Herpes-based Modular Expression System) platform that utilizes non-replicative herpes simplex virus type 1 (nrHSV-1) vectors engineered to deliver site-specific long-lasting therapies directly to target neurons while avoiding systemic exposure. Our lead product candidate, EG110A, has shown favorable safety and efficacy interim results in our first-in-human trial currently ongoing in four U.S. sites in patients with neurogenic detrusor overactivity (NDO)-related incontinence following spinal cord injury.

We believe our HERMES platform has the potential to overcome key limitations of conventional gene therapy approaches, including limited payload capacity, immunogenicity, off-target effects, challenges associated with repeat administration and high manufacturing costs, thereby providing us with potential opportunities to grow our pipeline of product candidates. Our second product candidate, EG142A, has now demonstrated encouraging preclinical activity in a series of animal models in different forms of chronic pain.

Job Description:

We are seeking a Clinical Data Scientist (based in Paris, France or in NYC, USA) with expertise in Clinical Intelligence to support the oversight of clinical study data throughout the lifecycle of our clinical trials. This role will work closely with Clinical Development, our external statistical and data management vendor to develop and implement a clinical intelligence framework for monitoring incoming blinded clinical data.

The ideal candidate will bring a strong foundation in clinical data management, combined with an understanding of clinical research, scientific concepts, and statistical data analysis. Experience in clinical data intelligence is preferred.

The ideal candidate should also have a keen interest in artificial intelligence (AI) and a proactive mindset towards exploring its applications in clinical data intelligence.

This individual will monitor the incoming clinical data and work with the external data management vendor into actionable clinical intelligence—identifying emerging trends, data quality issues, inconsistencies, and potential signals while maintaining appropriate study blinding and data integrity.

Main responsibilities include:

Clinical Intelligence & Data Monitoring

• Develop and implement approaches for data oversight and monitoring incoming blinded clinical study data and generating meaningful clinical intelligence outputs.
• Monitor data on an ongoing basis to identify trends, outliers, inconsistencies, missing data, data quality issues, and unexpected patterns.
• Develop dashboards, reports, visualizations, and other tools to provide timely visibility into the quality and status of clinical data.
• Establish appropriate data review metrics and thresholds to support proactive identification of potential issues.
• Identify trends that may indicate data quality issues or operational problems at a site or country level.
• Identify patterns across efficacy, safety, and laboratory trends, and other study data while maintaining study blind
• Partner with the internal clinical team, CRO clinical teams and data management from the external data management vendor to investigate and understand potential data issues.

Clinical Data Management & Vendor Collaboration

• Work closely with the external data management and statistical vendor supporting all clinical programs to understand data flows, data structures, and study-specific requirements.
• Collaborate with the data management vendor on data specifications, data transfers, data validation, and data review processes.
• Evaluate the quality and completeness of incoming clinical data and provide recommendations for improving data collection and management processes.
• Support development and refinement of data review plans, data quality checks, and automated monitoring approaches.

Data Integration & Analytics

• Work with our clinical study database at the external data management vendor across all clinical programs and other relevant data sources to integrate and analyze clinical trial data.
• Develop repeatable analytical workflows for ongoing data surveillance.
• Identify meaningful data trends and anomalies.
• Translate complex datasets into clear, relevant insights for clinical and operational stakeholders.
• Support the development of automated data checks and analytical algorithms where appropriate.
• Continuously improve the organization's ability to observe and monitor incoming clinical data proactively

Cross-Functional Partnership

• Partner with Clinical Development, Data Management, Biostatistics, and other functions to understand the clinical context behind the data.
• Communicate findings clearly to both technical and non-technical stakeholders.
• Participate in study team meetings and data review activities as appropriate.
• Help establish best practices for clinical intelligence and data surveillance across studies.

Key Qualifications:

Education: Bachelor’s or Master’s degree in Biostatistics, Data Science, Biomedical Informatics, or a related field.

Professional experience:

• At least 5 years of relevant experience working as clinical Data manager in a CRO or Biotech or Pharmaceutical company or closely related function.
• Strong understanding of clinical trial data and clinical research concepts.
• Hands-on experience working with clinical study databases and clinical data management systems.
• Strong knowledge and experience in AI usage in Data analysis/Clinical Intelligence
• Experience reviewing and assessing clinical data for quality, completeness, consistency, and trends.
• Strong analytical and problem-solving skills with the ability to identify meaningful patterns in complex datasets.
• Working knowledge of statistical concepts and data analysis.
• Experience working with external clinical data management, statistical, or CRO vendors.
• Experience working in a blinded clinical trial environment.
• Strong proficiency with SQL and/or analytical programming languages such as Python or R.
• Experience with data visualization and reporting tools.
• Experience in data management of clinical trials in neurology or neurology-urology indications preferred.
• Ability to translate analytical findings into actionable information.

Soft skills:

• Analytical Thinking & Scientific Curiosity
• Proactivity & Problem-Solving
• Cross-functional Collaboration & Communication
• Autonomy & Adaptability

Languages: English (spoken and written)

Cyllene Therapeutics is an equal opportunity employer. We welcome applicants of all backgrounds and do not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected characteristic.