Play an active role in the planning and
design of clinical studies, solve discrepancy queries and suggest solutions for
database design. Create CDISC SDTM Domain specification and data definition
(Define.xml) documents. Annotate and define, according to company standards,
any new data elements that are required and also provide updates to the
dictionary to accommodate new or expanded CRF specifications. Work on data
mapping from existing raw data to CDISC SDTM Standard, data mapping from SDTM
to ADaM Domains and review CRFs (Case Report Form) to ensure consistency in
collecting data to meet objectives defined in protocol. Develop various macros
to ease the implementation of various standard procedures for mapping variables,
generating views and creating tables, listing and reports. Develop conversion,
loading and merging programs using SAS programming to transfer non- CRF data
(PK, ADA, HAHA, LAB) into OC database. Create SAS datasets by mapping the
variables from OC views and also responsible for extracting Raw datasets. Run
routine conversion and loading programs to check the consistency of data sent
from various labs using SAS. Perform SAS programming (SAS/BASE, SAS/STAT, SAS
MACROS, SAS/ACCESS, SAS/GRAPH), Object Oriented Programming, PL/SQL and UNIX
with remarkable deadline sensitivity. Responsible for validating programs and
produce RTF, HTML and PDF output formats using SAS/ODS. Work in coordination
with Biostatisticians, SAS programming team, and Clinical Data Managers. Will
work in Glastonbury, CT
and/or various client sites throughout the U.S. Must be willing to travel
and/or relocate.