Job Description :
TITE : Clinical SAS Programmer
LOCATION : Woodcliff Lake, NJ
Duration : Contract-Hire
Visa Status : UZ CITIZEN , GC, EAD-GC,
H1B and OPT EAD are Engourages to Apply for this position
RESPONSIBILITIES:
We have mutiple openings for Sr SAS programmers for one of our pharma clients in NJ
Location : Woodcliff Lake, NJ - 07677
Term : 1 Year
The position require a senior level that can handle a project with minimum supervision. We need someone w/ Neuroscience experience.
This position is responsible for supporting the phase 3 clinical trial, including but not limited to, as outlined below:
Responsibilities :
Reviews SAP, TLG shells and variable derivation rules and provides feedback
Develops Study Quality Surveillance Plan and monitors study conduct to proactively address issues to ensure high quality study data
Develops the Data Monitoring Committee charter in collaboration with other functions and liaises with independent statisticians
Reviews the SAP, provides feedback to the statistician and develops (with the statistician) study specific dataset specs
Performs and validates statistical analysis
Independently reviews CSRs and performs data interpretation
Supports submission strategy planning, regulatory communication and development of Health Authorities responses
Creates/ validates the eSubmission components (transport datasets for both SDTM & ADaM, Annotated CRF, define documents)
MS in Biostatistics/Statistics preferred, with at least 5 years of experience in the pharmaceutical, CRO or biotech industry.
Strong SAS programming skills, with experience in SAS-Base, MACRO, STAT, and GRAPH.
Strong CDISC data standards, e.g. SDTM and ADaM
Good technical writing skills.
Good communication skills with strong verbal, written and interpersonal communication skills.
Strong organizational skills with ability to effectively manage multiple projects.
Strong teamwork ability/commitment and individual initiative.
Proven experience with UNIX and Windows operating systems.
Understanding of the software development life cycle.
Understanding of FDA guidelines.
Good organization, time management and attention to detail skills
needed to work in a stressful environment under tight deadlines while
maintaining focus on details and quality.
Applies good judgment and demonstrates initiative to resolve issues.
HR