Agios Pharmaceuticals is searching for a dynamic Manager, Senior Clinical Data Programmer to join our growing Clinical Data Systems team. The Manager, Senior Clinical Data Programmer will be responsible for providing Clinical SAS Programming and QC support to study teams and provides technical leadership on CDISC Standards and SDTM deliverables. This position will provide support for the development, delivery and validation of SDTM Datasets and SDTM Submission deliverables. This position also provides support for the development, testing and delivery of data review tools developed in SAS or other programming and visualization tools as required.
- Independently develops SAS or other programs, and specifications to create and/or validate clinical datasets in CDISC SDTM format for all study deliverables as assigned.
- Develops programs to assist with data review by creating data listings per internal data review plan (IDRP).
- Effectively designs and codes SAS programs for assigned project(s), consistently meeting objectives of the project
- Codes complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic submissions of data in CDlSC SDTM format with minimal instruction or input from supervisor
- Provides guidance on the resolution of highly complex clinical trial reporting problems within budget and timeline constraints, while assuring high quality standards
- Performs quality control checks of advanced SAS code and output produced by other Statistical Programmers. Program/validate SDTM datasets including define.xml and SDTM reviewer's guide
- Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications, datasets, define.xml, SDRG, Annotated CRF)
- Review the Study EDC specification and Study SDTM Mapping specification and ensure all collected study data (including external) is mapped appropriately in target SDTM model
- Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and other Quality tools
- Performs other duties as assigned
- B.S. (or equivalent degree) and 8 - 10 years of relevant work experience in biotech/pharmaceutical industry
- Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
- Demonstrates advanced knowledge of electronic submissions and CDlSC SDTM
- Demonstrates in-depth knowledge of FDA/ICH guidelines, GCP regulations, industry/technology standard practices and good programming practices
- Demonstrates in-depth understanding of regulatory, industry, and technology standards and requirements
- Demonstrates in-depth understanding of statistical terminology, clinical tests, medical terminology, and protocol designs
- Experience working with Pinnacle 21 Enterprise for validating the SDTM datasets and creation of SDTM Submission package deliverables.
- Displays good organizational skills, problem-solving abilities, time management skills and initiative.
- Communicates effectively in verbal presentations and written technical reports to both internal and external customers
- Proven record of effective and successful project management tasks and skills
- M.S. (or equivalent degree) and 5 - 8 years of relevant work experience
- Experience in Clinical Data management and/or trial management experience with technical expertise in clinical data standards management and implementation.
- Experience using relational databases (e.g., SQL Server)
- Understanding or knowledge working with data from EDC systems like Medidata Rave
- Experience working with external vendor data and management of imports/exports and data transfers.
- Experience performing SDTM Mapping programming with tools like elluminate SDTM Mapper module.