Summary

Elephas, a Madison, WI-based biotechnology start-up company, is seeking a highly motivated Clinical Data Analyst. The Clinical Data Analyst is directly responsible for design, curation, and quality of clinical data from trials and studies. This position is critical for turning raw clinical data into meaningful insights that inform product development, regulatory submissions, and strategic decisions. This person works at the intersection of clinical data science, medical affairs, and biostatistics. This role will have cross-functional duties with software, commercial and other departments. Understand the clinical patient journey, what data points to collect, and how to interpret the data based on industry-standard guidelines and labels. This position will be the champion of our clinical data and help internal stakeholders leverage the data for many use cases. The Clinical Data Analyst will be a critical thinker with high attention to detail and deep expert knowledge of clinical oncology data. Applicants should be comfortable in a fast-paced and highly collaborative environment.

Job Duties/Essential Functions

• Support and scale curation of basic clinical/pathological data of incoming samples
• Collect and harmonize data from multiple studies (e.g., across different sites, indications, or protocols)
• Reconcile variations in terminology, units, and measurement approaches
• Responsible for overall clinical data quality and supporting the build out of quality mechanisms
• Collaborate on building of eCRFs/EDC, data models, and clinical data architecture and governance
• Define and calculate derived variables like time-to-progression, response rates, and durability of response
• Identify clinically meaningful trends in industry trends (ontologies)
• Investigate unexpected results or inconsistencies in data
• Contextualize findings with background incidence rates or historical controls (benchmarking)
• Partner with clinical development, medical affairs, and regulatory teams
• Translate statistical outputs into clinician- and executive-friendly language
• Collaborate with commercial team and provide input into publications, advisory boards, and investor materials
• Acts as a cross functional subject matter expert (SME) for clinical data across the organization
• Interact with CROs, consultants, customers, and others as SME, as needed

Competencies

• Attention to detail
• Intermediate experience with Excel
• Ability to work both independently and as part of a team
• Strong interpersonal, written, and verbal communication skills
• Willing to be an active individual contributor
• Familiarity with relevant data model and ontologies (OMOP, ICD10, ICD03, NDC, SNOMED, etc.)
• Data analysis skills and prefer experience running basic queries (ie. SQL)
• Ability to support strategic efforts around data quality and curation
• Ability to work cross-functionally

Required Education and Experience

• Bachelor’s Degree or higher in life or medical sciences
• 10 + years of data curation experience in oncology
• Experience working with a clinical trials team preferred
• Understanding of regulatory compliance practices – Good Clinical Practice (GCP), 21 CGR Part 11, ISO 14155, and HIPPA preferred

Certifications/Specializations

• Oncology Certified Nurse (OCN) or Oncology Data Specialist (ODS) preferred
• GCP for Clinical Investigations of Devices certification preferred

Benefits

We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.