Senior Clinical Programmer (SDTM SME)
Company: IQVIA
Location: New York
Posted on: March 19, 2023
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Job Description:
Position Purpose
In this role the incumbent supports interface departments, e.g.,
Biostats, Data Management with the (SAS) programming of requests,
following standard procedures and work practices to ensure quality
control and accurate versioning of analyses that are appropriate
for regulatory submissions and publications.
The development of programming scripts for data retrieval,
transformation and representation as well as their validation will
be the main focus of this role.
The role leads the development and maintenance of data quality
standards and performs the necessary programming and validation
steps to ensure that regular and on-demand data quality control can
be performed in clinical studies. The role will support the
clinical study team with the identification, specification, and
implementation of relevant listings and reports to ensure that
adequate data quality will be achieved for clinical trials.
Furthermore, the role will lead the development and implementation
of programs to ensure the quality of data deliveries as they are
provided by contract research organizations. These are mainly but
not limited to eCRF raw data, datasets in submission ready standard
format (SDTM, ADaM), and data from external sources as they have
been collected in clinical trials (e.g., IxRS systems, eDiary,
central laboratory, central ECG) and their related
documentation.
Main Responsibilities and Accountabilities
Collaborates with the clinical study team in developing ongoing
data quality standards and clinical data acceptance rules for
clinical data in the eCRF and related external data sources
collecting data from clinical studies.
Leads the implementation and maintenance of internal data quality
control programs, acceptance criteria for data from external
sources and performs the related programming.
Leads the set-up and maintenance of a suite of reports that
function as a sample report library for study teams to choose from
in order to help them efficiently lead their projects.
Leads the implementation and organization of automated regular
reports on study platforms and oversees correct processing of
automated reports.
Collaborates with peers, data management and statistics to ensure
the quality and accuracy - thus submission readiness - of clinical
data as required by authorities (i.e. SDTM, ADaM, define.xml).
Supports the review of related deliverables.
Leads the development of Data Visualization tools providing
information about data quality, study metrics, etc.
Performs data storage in a format that allows pooled analyses and
exploration of legacy data and ensures a smooth data retrieval
processes
Additional tasks:
Supports CR&D staff in any data standards related
questions.
Collaborates in the development of strategies for the integration
of non eCRF data in the eCRF database, provides technical support
to internal team members as well as to external vendors as
requested by study team.
Leads data exchange with other CR&D groups like e.g.
Statistics, Pharmacometrics, Medical Writing & Disclosure etc.
Perform statistical analyses and SAS programming to:
support responses to regulatory agencies
support clinical safety monitoring of safety signals
generate integrated summary of safety and efficacy
support publications and presentations
support planning and reporting of clinical trials via exploratory
analyses of available data
replicate CRO and CSL statistical analyses for QC
Position Qualifications and Experience Requirements
Education
Degree (BSc/MSc/Diploma) in Computer Science,
Mathematics/Statistics, or related area with relevant
experience.
Other degrees and certifications considered if commensurate with
related data management experience.
Experience
At least 5 years of experience in either clinical data management
and/or statistical programming, within the CRO/pharmaceutical
environment.
Understanding of data management and/or statistical programming
processes and standards.
Knowledge in statistical programming using the SAS software or
reports programming in reporting tools such as Business Objects or
J-Review.
Knowledge in CDISC standards (CDASH, SDTM, ADaM)
Ability to work effectively in a team setting, and to meet set
goals by managing own timelines
Ability to work in cross-functional, multicultural and
international clinical trial teams.
Competencies
Good communication and analytical skills.
Good planning and organizational skills.
Ability to work successfully in a matrix organizational
structure.
Networking skills and ability to share knowledge and experience
amongst colleagues.
Fluent in English, oral and in writing
IQVIA is a leading global provider of advanced analytics,
technology solutions and clinical research services to the life
sciences industry. We believe in pushing the boundaries of human
science and data science to make the biggest impact possible - to
help our customers create a healthier world. Learn more at
https://jobs.iqvia.com
We are committed to providing equal employment opportunities for
all, including veterans and candidates with disabilities.
https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA's ability to
operate and provide certain services to customers and partners
necessitates IQVIA and its employees meet specific requirements
regarding vaccination status.
https://jobs.iqvia.com/covid-19-vaccine-status
IQVIA is a world leader in using data, technology, advanced
analytics, and expertise to help customers drive healthcare - and
human health - forward. Together with the companies we serve, we
are enabling a more modern, more effective and more efficient
healthcare system, and creating breakthrough solutions that
transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore
new possibilities. No matter your role, everyone at IQVIA,
including our colleagues at Q - Solutions, contributes to our
shared goal of improving human health. Thank you for your interest
in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Keywords: IQVIA, New York , Senior Clinical Programmer (SDTM SME), IT / Software / Systems , New York, New York
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