Clinical Data Scientist

About The Company

Harnham is a leading recruitment and consulting firm specializing in data, analytics, and digital transformation across various industries, including healthcare, finance, marketing, and technology. With a strong global presence, Harnham is committed to connecting top-tier talent with innovative organizations to drive data-driven decision-making and operational excellence. The company prides itself on its deep industry expertise, personalized approach, and dedication to fostering long-term partnerships. Harnham's mission is to empower organizations by providing skilled professionals who can harness the power of data to generate actionable insights, improve processes, and achieve strategic goals.

About The Role

Harnham is seeking a highly skilled Clinical Data Scientist to join our client's dynamic team, supporting their efforts in clinical research and regulatory submissions. This role offers the flexibility of a hybrid or fully remote work arrangement, with a preference for candidates located in the San Francisco Bay Area. As a Clinical Data Scientist, you will play a pivotal role in transforming complex clinical datasets into analysis-ready formats, ensuring data quality, integrity, and compliance. Your expertise will directly contribute to the success of clinical trials and the advancement of innovative healthcare solutions. You will collaborate closely with cross-functional teams, including Clinical Operations, Data Engineering, and AI/ML specialists, to develop robust data pipelines, automate workflows, and deliver insightful analyses that support strategic decision-making and regulatory compliance.

Qualifications

Education: A Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field is required.

Experience: A minimum of 2-5 years of experience in clinical data science, statistical programming, or clinical data management within pharmaceutical, biotech, or related environments is essential.

Technical Skills: Proficiency in SAS, R, Python, and SQL is mandatory. Familiarity with version control systems such as Git is preferred. Experience working with CDISC SDTM and ADaM standards is highly desirable. Knowledge of oncology endpoints, RECIST criteria, survival analysis, and real-world data (RWD) will be advantageous.

Core Competencies: Demonstrated expertise in cleaning and integrating complex datasets, including unstructured text or NLP-derived data. Exceptional attention to detail, accuracy, and data validation skills are critical. Strong written and verbal communication abilities are necessary for effective collaboration and documentation. Candidates should be self-motivated, curious, humble, and capable of working independently while thriving in a team environment.

Responsibilities

• Convert raw, manually abstracted, and AI-processed clinical data into standardized formats such as CDISC SDTM/ADaM or client-specific data models to facilitate analysis and reporting.
• Develop analysis-ready datasets from diverse sources, including electronic medical records (EMRs), electronic data capture (EDC) systems, and internal abstraction tools, ensuring data consistency and quality.
• Create and generate Tables, Listings, and Figures (TLFs) for clinical study reports and interim analyses using SAS, R, or Python, supporting regulatory submissions and internal decision-making.
• Perform comprehensive data cleaning, validation, and discrepancy investigations to distinguish true clinical signals from upstream data errors, maintaining high standards of data integrity.
• Collaborate with engineering teams to automate data cleaning, validation workflows, and pipeline processes, enhancing efficiency and reproducibility.
• Serve as an internal customer and early tester for new data infrastructure tools, providing feedback to improve usability and functionality.
• Develop and maintain detailed documentation, including data specifications, derivation logic, reviewer guides, and Define.xml files to support audits, regulatory reviews, and knowledge sharing.

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• Support ad hoc and exploratory analyses by responding to data queries, conducting one-off analyses, and providing insights that demonstrate the value of the data platform.
• Ensure all data management activities comply with privacy, security, and regulatory standards, such as HIPAA, promoting ethical handling of sensitive clinical data.
  
  

Benefits

Joining Harnham's client as a Clinical Data Scientist offers a comprehensive benefits package designed to support your professional growth and personal well-being. You will be eligible for a competitive salary commensurate with your experience and qualifications, along with performance-based bonuses and equity options. The organization provides a flexible work environment with hybrid or fully remote options, fostering work-life balance. Additional benefits include health insurance coverage, retirement savings plans, paid time off, and professional development opportunities. The company also emphasizes a collaborative culture that values innovation, continuous learning, and diversity, ensuring you have the resources and support needed to excel in your role.

Equal Opportunity

Harnham is an equal opportunity employer committed to fostering a diverse and inclusive workplace. We do not discriminate based on race, ethnicity, gender, sexual orientation, age, disability, religion, or any other protected status. We believe that diverse perspectives and experiences drive innovation and excellence, and we are dedicated to providing equal employment opportunities to all qualified candidates. Our hiring practices are designed to promote fairness and transparency, ensuring that every individual has the opportunity to contribute and succeed within our organization.