ConcertAI is the leading provider of precision oncology solutions for biopharma and healthcare, leveraging the largest collection of research-grade Real-world Data and the only broadly deployed oncology-specific AI solutions. Our mission is to improve translational sciences; accelerate therapeutic clinical development; and provide new capabilities for post-approval studies to accelerate needed new medical innovations to patients and to improve patient outcomes.
ConcertAI has emerged as one of the highest growth technology companies in Real-world Data and AI, backed by industry leading private equity companies: SymphonyAI, Declaration Partners, Maverick Ventures, and Alliance|Bernstein.
Our engineering team is looking for a technical, service-oriented, talented Senior Clinical Data Analyst. In this role, you will design clinical data solutions as part of our Eureka SaaS platform. You will be primarily responsible for the generation of functional mapping documentation to be used by the software development team in the eurekaSaaS platform for Clinical Trials.
- Implementation of CDISC standards including SDTM mapping, analysis datasets specifications, creation of Define.xml files, etc.
- Design, develop, process and analyze data collections and processing from diverse sources, large scale structured and unstructured data
- Collaborate with the Quality Assurance team to test the application functionality
- Provide technical guidance, training and support to other team members
- Ensure compliance with industry quality standards, regulations, guidelines and procedures
- Manage multiple timelines and deliverables (for single or multiple clients) and managing client communications as assigned
- Minimum 5 years' experience in biostatistics and/or regulatory submission
- Strong experience within data conversion or implementation of validation rules
- Experience within CDISC, SDTM mapping and/or creation of ADAM datasets, and Define.xml files
- Extensive knowledge of clinical trial data - CDISC SDTM or ADAM standards – HL7 FHIR a plus
- Experience and understanding of standard medical vocabularies e.g. LOINC, RxNorm, SNOMED CT
- Strong interpersonal, communication, writing, presentation and facilitation skills
- Detail-oriented with exceptional follow-through and superior organizational skills
- Ability to communicate with technical teams (e.g. developers and engineers) effectively to drive effective issue resolution
- Proven ability to work both independently and as part of a team; experience working as part of a distributed team
Optional, but desired
- Experience with successful implementations of CDISC Standards and preparation of study data for regulatory submissions
- Understanding of database design principles and best practices
- Experience in designing scalable, modular SQL code and ETL procedures
- Experience working in a cloud environment
- Strong Software Development Lifecycle experience (Agile methodology experience is a plus)
- Excellent understanding of relational database concepts, data modeling and design
- Strong troubleshooting skills and use of defect/feature management systems
- Proven ability to work independently and with technical team members (Startup environment experience is preferred
- Experience in the Biotechnology, Pharmaceutical, or Life Sciences industries (Clinical Research Organization - CRO or Clinical Trial regulated environment preferred)
- Exceptional attention to detail along with strong communication skills
- Bachelors degree in a quantitative discipline or engineering
Learn More About ConcertAI
ConcertAI is transforming how healthcare is delivered and dedicated to improving patient outcomes in oncology by offering innovative solutions on how data and intelligence is used to solve healthcare problems. We are creating something special in our culture, by building a collaborative, engaged, patient focused, team approach to our mission. Our high-performance teams are looking to add great talent to the mix and we are hiring for the right mix of new skills and diverse mindset. Learn more about ConcertAI at www.concertai.com or on LinkedIn .