*Hi I hope you are doing well. Given below are the multiple requirements
from one of our direct client,which can be filled immediately. Kindly
respond to this requirement with your consultant resume, contact and
current location to speed up the interview process. Job#1:Title: SAS
ProgrammerLocation: 10 positions in Hamilton, NJ and NC locations. (Remote
Work from Home)Duration: 6 Months extendable contractSenior SAS computer
programming position working with clinical trials data. Primary
responsibilities include providing clinical data management and
biostatistical programming support for various phases of clinical studies.
Activities include importing/exporting data, reformatting raw data to CDISC
(SDTM & ADaM) and/or client specified analysis standards, programming
and/or validating analysis data sets, tables, listings, graphs, TLFs, ad
hoc reports and regulatory submission deliverables such as ISS, ISE, and
eCRT and Define documents. Assists Data Management and Biostatistics with
developing tools and techniques for improving process efficiencies.
Communicates effectively within a multi-disciplinary project team to
complete assigned tasks on time and within budget. Resolves issue
escalation for lower level programmers. Reviews and makes recommendations
for process development and improvement. Job Scope: Contributes directly
to the company's revenue by performing programming and validation of client
deliverables in Data Management and Biostatistics. Successful completion of
assigned tasks increases the likelihood of repeat business from the client
and ongoing success in acquisition of new business. Qualifications:
Minimum Required Education and Experience: * BA/BS or equivalent degree in
computer science, statistics, biostatistics, mathematics or related field
and at least five Job#2:Title: SAS ProgrammerLocation: Bridgewater,
NJDuration: 6 Months Extendable contractProvide statistical programming
expertise in SAS for the production of analyses, tabulations, graphics, and
listings from clinical trial data. Key responsibilities and skills include,
but are not limited to, the following: Contribute to the preparation of
analysis plans. Prepare, document and test required programs and procedure
data displays in an efficient manner for inclusion in integrated clinical,
statistical reports and other similar reports. Contribute to the integrated
clinical/statistical report and other similar documents. Ensure analysis
data and programming code meet regulatory and company standards and are
consistently structured to permit efficient programming and reporting.
Perform quality assurance procedures on work performed by others. Develop,
test, validate, document, maintain and execute software and/or systems
using the currently endorsed tools or support of production activities.
Assist in the integration of data from remote entry sites, contract
organizations and co-licensing partners to the central database.
Therapeutic area is internal medicine Required Skills: Understands the
basic skills and goals of reporting clinical data. Writing knowledge of
SAS; SQL and UNIX. Proven ability to organize workload and priorities and
complete tasks on time. Demonstrated ability to work effectively in a team
environment. Strong interpersonal skills and ability to communicate
effectively. Ability to identify and solve technical problems. Experience
in CDISC Version 2,3 preferred. Strong experience in SAS analytical
database design a MUSTEducationMust have a science degree and 2+ years
working in a pharmaceutical / research environment. Advanced degree in
Science or Mathematics Job#3:Title: Sr. SAS ProgrammerLocation: Rahway, NJ
or North Wales, PADuration: 6 Months ContractSr. SPA should have led at
least one FDA filing and should have led complex studies from E2E for at
least 2-3 years (including managing junior programmers). This person is
accountable for compound level deliverables.Relevant experience involving
statistical programming in the clinical trials environment or Masters
Degree with 4 years relevant experience involving statistical programming
in the clinical trials environment- Must have team leading experience in
mentoring junior SAS programmers.- Minimum 5 years' Base SAS programming
experience and basic statistical procedures required- Minimum 1 year
experience implementation of CDISC industry standard, SDTM, ADAM Preferred
Qualifications:- Advanced SAS Macro Language- SAS/GRAPH- SAS/SQL-
SAS/STAT Job#4:Title: Statistical ProgrammerLocation: Wayne, PADuration: 12
Months Extendable contractProvide statistical programming support as well
as operational guidance and coordination for assigned projects and act as a
project statistical programmer with the advice of SHIRE teams;·
Support the preparation of clinical trial reports and, if necessary,
integrated summaries of effectiveness and safety, using appropriate
statistical, and clinical trial methodologies, and computer
applications;· Perform QC of tables and programs developed or
produced by SHIRE Teams or by Clinical Research Organization (CRO)
personnel;· Performs exploratory analyses of data;·
Actively participate in preparation of abstracts/presentations/manuscripts
based on clinical study data and interact with members of SHIRE teams,
Marketing, DRA, Medical Data Management, Biometrics, and Medical and
Scientific Affairs personnel to accomplish the major job objectives. and
· Interact with CROs to ensure efficiency and quality in completion
of statistical activities contracted out for assigned clinical trials.
· Participate in o the development of project plans,
protocol design and development o the development of trial validation
plans and source data verification planso the preparation of documents
needed for Reporting and Analysis meetings (table/figure/listing shells and
programming specifications).o the preparation of
abstracts/presentations/manuscripts· Prepare o statistical mock
up tables of protocols which will be approved by the project statistician
or group head o statistical files/programs for submission to health
authorities, if necessaryo statistical programming sections of clinical
trial reports which meet the statistical guidelines of the departments and
health authorities· Review CRFs for soundness of trial design and
discuss comments directly with clinical research personnel/project
statistician/group head · Review and attend Protocol Review
Committee meetings when necessary· Review and approve statistical
program deliverables prepared by external groups· Provide guidance
in the preparation of data listings, summary tables, graphs and statistical
analysis files. · Manage activities related to data analysis,
report preparation, transfer of data to and from CRO, and archiving of
clinical trial data, output and programs following SHIRE processes
· Perform QC of the tables and programs developed by other
statisticians and programmers · Perform exploratory analysis of
data · Any other related tasks as directed by supervisor
Job#5:Title: Biostat programmer Location: Woodcliff Lake, NJDuration: 12
Months contract Biostat programmer Oncology PCU To support the
Biostatistics team by carrying out and overseeing programming activities of
statistical programmers and external vendors (as required), and to ensure
timely and accurate programming and validation activities for clinical
studies. Contributes to the overall efficiency and best practice running of
the Biostatistics group, demonstrating the ability to work efficiently and
to a high standard within a clinical team environment. Main
duties/responsibilities: 1. Providing statistical programming and
validation support for clinical study reports, overseeing programming
activities by external vendors (e.g., CROs) when necessary and coordinating
programming activities among the study programmers to achieve timely
progress in the following areas: analysis datasets, statistical tables,
figures, listings, Integrated Summaries of Safety (ISS), Integrated
Summaries of Efficacy (ISE), electronic submissions and other internal and
external requests (e.g., publications). Accessing and converting data to
SAS from Database management system and PC file formats (e.g., MS Excel,
text files). Working with external vendors in order to develop or monitor
the content and structure of SAS data sets. 2. Developing and maintaining
SOPs, SWPs and other related technical documents, providing input to the
Database and CRF Development, creating edit check programs and providing
feedback to the Data Management. Providing input in developing statistical
analysis plans, specifications of analysis datasets, validation plans, and
other related documents. Determining and researching SAS software upgrades
and related systems and addressing maintenance issues. 3. Managing and
developing team, maintaining standards for programming activities, and
guiding/coaching Statistical programmers. 4. Working independently to
accomplish tasks and goals defined by supervisor. Attending required
training and meetings and bringing in new ideas to improve the programming
process. * Responsibilities weighting may change significantly based on the
incumbent and their assigned areas of responsibility. Qualifications and
education required: * Minimum of Bachelor's degree in Statistics, Computer
Science, Mathematics, or a related science discipline. Masters preferred.
Experience required: * Minimum 5 years experience in SAS programming for
phase I-IV clinical trials in a pharmaceutical/CRO environment. 7+ years
experience preferred. * Some project experience in a pharmaceutical/CRO
programming environment or demonstrated significant leadership of SAS
programming activities in a clinical pharmaceutical/CRO environment. Skills
and aptitude required: * Experience using SAS-Base, MACRO, STAT, GRAPH,
ACCESS, MS Office. * 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. * Strong
verbal, written and interpersonal communication skills needed to work
effectively in a team environment, managing that team as required Thank
you,*Venu
SBS Info Systems LLC.
[email protected]
703-349-1138
An "E-Verify" Company SBS Info Systems
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