Clinical SAS Programmer
About the job
ICON plc is a world-leading healthcare intelligence and clinical research
organisation. From molecule to medicine, we advance clinical research
providing outsourced services to pharmaceutical, biotechnology, medical device
and government and public health organisations. With our patients at the
centre of all that we do, we help to accelerate the development of drugs and
devices that save lives and improve quality of life. Our people are our
greatest strength, are at the core of our culture, and the driving force
behind our success. ICON people have a mission to succeed and a passion that
ensures what we do, we do well.
Responsibilities:
Services rendered will adhere to applicable SOPs, WIs, policies, local
regulatory requirements,
Provides expertise in planning, creation and oversight of clinical programming
activities and deliverables from study set-up to submission ready CDISC SDTM
tabulation packages (aCRF, define.xml, cSDRG, etc.).
Review and provide input into all trial set-up documentation.
Responsible for review or creation of aCRF, DTA metadata and trial design
specifications.
Create or review mapping specifications for internal data and/or SDTM
Generate or review internal data and/or SDTM datasets using internal
conversion framework, utilities, and global checks Ensure quality review of
all datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are
available for stakeholder use (medical review, central monitoring, adaptive
design, etc.) and compliant for interim and final database
Program, or oversee programming of, quality review checks and reports for use
by Data Managers and other team
Responsible for creation of submission-ready SDTM packages for FDA/PMDA or
other regulatory authority submissions and keeping abreast in changing
regulatory
Responsible for acquiring and maintaining working knowledge in the various and
future evolving data collection tools applied in the clinical trial space such
as Medidata Rave, Clinical Data Tools such as LSAF, Pinnacle 21, and in CDISC
standards such as SDTM, CDASH, Controlled terminology and xml.
Support the development of standards and drive their implementation within the
organization.
Candidate requirements:
Clinical programming experience and experience working on a clinical trials.
Bachelor’s degree or higher and/or equivalent in computer science, data
science/data engineering, mathematics, or another relevant scientific field
(or equivalent theoretical/technical depth).
Expert knowledge of SAS programming, Define.xml, SDTM aCRF, cSDRGs.
Expert knowledge of data structures (e.g., CDISC SDTM, ADaM) and their
implementation.
Experience working in highly diverse teams within clinical research; cross-
functional, global, multiregional.
Project management skills.
Highly organized with excellent written and verbal communication.