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Hope you are doing
great,
Please let me know
on [email protected].if you
have any good resources for the below position
mentioned
Role: SAS Programmer
Analyst-SDTM Experience
Location: Northern, NJ-Bergen
County
Duration: 12
Months
Start: ASAP
Interview: phone
JOB
DESCRIPTION
SAS Programmer
Analyst with very strong proven hands-on experience in SDTM-In the areas of
Mapping, Related Data Structures, validation utilizing OpenCDisc and
programming.
The
candidate MUST have the ability to interview on-site with the client after a
phone screen is completed.
The
experience with SDTM is very important to this role, and a candidate without
this type of hands-on experience cannot be considered.
Daily
Responsibilities:
Responsible
for SDTM data creation and delivery for oncology studies.
Prepare SDTM
Mapping specification following company standards.
Create or participate in
SDTM annotation for CRFs/eCRFs for oncology trials.
Develop programs to
create SDTM datasets and Define.xml for statistical analysis, tables &
listings, and regulatory submissions.
Perform Open CDISC validation,
coordinate to resolve issues, prepare associated documentation
Design and
develop SAS macros, applications, and other utilities to expedite SAS
programming activities and usage by the Oncology Data Management and other areas
of Clinical for data review.
Ensure all programming activities and processes
performed are conducted according to standard operating procedures, good
programming practices, and GCP
guidelines.
Qualifications:
BS or MS in Computer Science
or related field.
Five to Seven years of strong experience in programming
with clinical trial data and developing programs, testing, and
documentation.
Strong SAS programming skills required in Windows and UNIX
environment, with proficiency in SAS/Base, SAS Macros, SAS/Graph,
SQL.
Extensive experience of handling SDTM mapping, related data structures,
and programming to create SDTM data sets.
Extensive experience in SDTM
validation using OpenCDisc..
Good knowledge in developing Define.xml and
validation.
Extensive experience of handling external data, e.g., laboratory
data, PK, ECG, Biomarker, Imaging, etc.
Good understanding of standards
specific to clinical trials, such as CDISC, SDTM, MedDRA, WHO DRUG.
Good
understanding of relational databases, e.g., ORACLE; Knowledge of the EDC
System, InForm and underlying data structure is a plus.
Knowledge of using
JReview/IReview is a plus.
Strong problem-solving skills.
Able to work
independently and as a team player; Good organizational, time management, and
project management skills.
Capable of communicating technical
concepts.
Good understanding of system development life cycles, GCP, and
related Regulatory guidelines.
Should be able to manage the assigned projects
independently with minimum supervision.
Thanks,
Samir
Reddy Technical
Recruiter
Contact:
813-862-1576
E-mail:
[email protected]
Web: www.riderconsultinginc.com
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