Hi All,I do have below requirement which is for our Direct Client. Please let me know your are interested.Title: Manager -
Biostatistician
Location: Woodcliff Lake, NJ
Duration: Long Term (12+
Months)
Description:
·         Work
with the clinical study team on study design, development and/or review of
clinical study protocols.
·         Develop
and/or review statistical analysis plans, including Table/listing/figure
shells, and final study report for clinical studies;
·         Work
with clinical data managers on design/review of case report form, data transfer
specification, edit check specification, and participation in user acceptance
testing (UAT); generate/review data tables/listings and coordinate data review
meetings during the course of the study to ensure data quality.
·         Oversee
programming activities, perform quality assurance checks on internally or
externally produced SAS tables, listings, and figures, and ensure the quality
of deliverables. Perform post-hoc statistical analyses as needed.
·         May
work on submission teams as a statistician and/or a programmer.
·         Generate
and QC outputs for publications; review publication (abstract/manuscripts) to
ensure accuracy, quality and soundness of statistical methodologies
·         Will
serve as lead Statistician on complex trials and across multiple studies.
·         Project
work including participating in the development of Clinical Development Plans
(CDPs) and the protocol development process, developing and implementing
Statistical Analysis Plans (SAPs), supervising CROs and interfacing with
co-promoters, attending IPT meetings, consulting with clinical or regulatory
affairs groups on strategic issues related to compound development, study
designs, analysis, resource needs and future plans.
·         Managing
non-project work including infrastructure development initiatives and
involvement in committees working to develop SOPs and SWPs to improve quality,
efficiency and timeliness of work processes
 
QUALIFICATIONS NEEDED:
·         Must
have a MS in Biostatistics/Statistics with at least 10 years of experience or a
PhD in Biostatistics/ Statistics with at least 7 years of experience in the
pharmaceutical, CRO or biotech industry.
·         Strong
SAS programming skills.
·         Neuro
experience is required.
·         Ability
to effectively work on multiple projects
·         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 leads problem solving within the teamThanks,
Kishore Rao,
Phone : (732) 227-1772 Ext- 413 
Fax: (732) 909 2358
www.ittblazers.com  / Email: kishore@ittblazers.com