Job Description :
CDISC Developer
Location: Cambridge, MA
Client: Novartis
Interview: on-site
Novartis Institutes of Biological Resources'' (NIBR'') Informatics group is starting a new project, CODEx Phase I, to clean, map, transform, and load (ETL and CDISC domain mapping) Oncology clinical data sets into an Oracle 12C-based data warehouse for overall data assessment to further enable the search for and development of new biomarkers.
NIBR Informatics is looking for a contractor with solid knowledge of clinical data standards (CDISC), as well as excellent experience in software engineering. The contractor selected will perform data curation and ETL programming activities to support cleaning, domain mapping, and loading of multiple clinical data streams into an Oracle data warehouse.
Software development work will include the creation of scripting to automate data cleaning and loading where possible. New programming will also include development of metadata search tools to determine what datasets are loaded and available per patient or set of patients, across the Oracle clinical assessment data warehouse and a genomics database. Working with the Oracle data warehouse owner, there will additionally be API work needed to deliver found data in JSON format to Novartis informaticists and clinical scientists for use in searching for and developing new biomarkers.
6+ years of experience in developing/maintaining integration solutions within the life sciences – pharma/ biotech/ CRO
Duties and Activities Evaluates the client area application systems/programming requirements and processes (e.g. new enhancements or maintenance), in the preparation of application system specifications, and in the development, testing, and implementation of efficient, cost effective application solutions. Researches and evaluates alternative solutions, and recommends the most efficient and cost effective solution for the systems/program design and develops system specification. Design, realize and implement IT solutions, including: Devise technical design specifications, Support of Data and process modeling, Developing GUI¿s and prototypes, Developing and testing programs using the defined software development environment (e.g. Unit/integration testing) Delivery of programs to specification and agreed date. Support the implementation of standard software packages, including: Understand functional specifications in order to devise technical design specifications, Customize standard solution and developing additional functions/objects according to user requirements. Write project related documentation such as technical program design, user manual, etc. Prepare and execute unit and integration testing in support of projects and identify and document and deviations or errors. May work with client management to identify and specify business requirements and processes for development platforms, computing environments, software, hardware, technologies and tools. Essential Knowledge and Skills BA/BS degree and related industry experience Full life-cycle experience - including requirement gathering, data analysis, design, development, testing and systems implementation. In-depth knowledge of Oracle development including PL/SQL, SQL Loader and ETL tools. Knowledge of various design patterns including third-normal, denormalized, star schema and snowflake. Data warehousing design topologies including ODS, information factory, independent marts, and CDI. Experience in tools and platforms include: Toad, Erwin, DataStage, MetaStage, QualityStage, Trillium, Informatica, Syncsort, Control-M, Unix and Microsoft Operating Systems. Strong written and verbal presentation skills are required. Level III Job related experience of 7+ years with indepth knowledge of applied skills. In addition, indepth knowledge of particular skill specified by hiring manager.
- 6+ years of experience in developing/maintaining integration solutions within the life sciences – pharma/ biotech/ CRO
- Strong NodeJS and JavaScript for clinical programming skills required. Python/ R experience a plus
- Strong SQL Programming (Oracle) experience required – Oracle 12 preferred, with knowledge on JSON querying into a relational format
- Expertise in building RESTful web services using XML/JSON payloads, interacting with external web services, databases, and data warehouses, is required
- Knowledge of Linux/ Unix required. Familiarity with the use of AWS platform components helpful
- Experience with clinical CDISC SEND & SDTM standards (domain definition and controlled terminology) required.
-Strong experience in data mapping using CDISC 3.2 standards required. Experience in mapping safety and oncology data domains (identification, results, drug exposure, tumor response), especially biomarker and NGS data, from early clinical trials strongly preferred.
-Strong experience extracting, transforming, and loading (ETL) preclinical and clinical data from a variety of data sources to a target Oracle data warehouse required
- Understanding of Authentication & Authorization protocols
- Knowledge of SOA design principles and best practices required
- Knowledge of Novartis clinical data standards (NOVDD, NCDS, extensions to CDISC) and controlled terminology, if possible
- Excellent communication skills, both verbal & written, required
- Ability to work successfully in a fast-paced team environment. Must be responsible for proper completion of assigned tasks and duties
- Able to interact on an occasional basis with clinical customer groups to resolve queries as needed