Title: Statistical Programmer
Location: Pine Brook, NJ ( Best to be a Local )
Duration: Long Term
Pay: DOE
Interview Type: Telephonic + Skype
Seats Required: 3

Required:
Statistical Programmer with 7-15+ years experience supporting clinical
trials in the Pharmaceutical industry
Strong drug development background
experience programming all phases of clinical trials, with significant
NDA/submission experience
NDA submission experience is REQUIRED
Oncology experience a plus
Strong technical SAS programming skills required
familiarity with CDISC SDTM and ADaM
project management experience


Title: SAS Programmer
Location: Pine Brook, NJ
Duration: Long Term
Pay: DOE
Interview Type: Phone + Skype

Required:
5 to 7 years of SAS programming experience within the Pharmaceutical
industry supporting clinical trials, for example, working within the
Data Management or Biostatistics functions
Extensive knowledge of CDISC SDTM data structures
Prior knowledge and experience of mapping of clinical trial data from
legacy standards into conformant and compliant CDISC SDTM version
3.1.2 domains
Knowledge and experience of performing validation. Knowledge of
WebSDM, OpenCDISC checker or similar tools is a plus.
SDTM submission experience is a plus
Knowledge of the define.xml is a plus

Role Discription:
Working on 8 different FDA submissions during 2012, the contractor
will be required to perform validation/acceptance of mapped clinical
trials data from legacy standards into conformant and compliant CDISC
SDTM version 3.1.2 domains. The contractor will use various validation
techniques to confirm all data were mapped correctly and consistently.
WebSDM will also be used to check for conformance to SDTM 3.1.2.
Depending on the specific submission, the contractor will work either
within a team or individually to perform the validation. A vendor will
be assigned to perform the mapping of the data so direct
communication/feedback to the assigned vendor will be required.
Additionally, the contractor will support the mapping exercise for a
FDA information request – this will require 10 domains for 6 studies
to be mapped to SDTM+ format and will be managed jointly with assigned
programmers from the Biostats department. Submissions to be supported
include: Radium-223, Xarelto VTE, Regorafenib GIST, FC Patch,
Florbetaben, Sorafenib Thyroid, Gadovist Breast and Riociguat PHIMS


Title: Database Developer
Location: KS
Duration: Long Term
Pay: DOE
Interview Type: Telephonic + F2F

Required:
EXPERIENCE IN A PHARMA/BIO COMPANY
Expert level MS SQL (T-SQL) programming skills and basic VB
programming skills. 7+ years experience
Must understand jobs, stored procedures, views, functions, SSIS
packages and VB Scripts
Prefer candidates with intermediate experience using ASP.Net, C#.Net


Send Resumes to [email protected]

David Benzimen
732-665-6246!! 732 231 7458
[email protected]

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