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发帖数: 12276 | 1 Hello
My name is Maria Kardan and I am a senior Placement Manager with Experis (
formerly COMSYS) National SAS Business Analytics & Clinical Practice. I
came across your resume in our database and wanted to check your
availability for two Biostatistician positions I currently have. I have
attached the positions below for you to review. If you or anyone you know
would be interested in these positions please respond to this email with
your contact information. Thank you and have a great day.
1) Sr. Biostatistician
Northern California Telecommute with occasional travel onsite to client
12 month contract
Start date June 1, 2011
Job description
As part of a clinical development team, collaborates in the preparation and
review of protocol writing, CRF design and monitoring of ongoing clinical
trials.
Provides technical and strategic support into clinical development plans
For assigned clinical development project(s), provides statistically sound
clinical trials design, including clinical pharmacology trials and data
analysis input to meet project objectives.
Supports teams in the development and review of regulatory submissions such
as clinical protocols, INDs and pre-meeting packages.
Provides strategic and analytical supports appropriate for exploratory
project activities such as biomarkers and PK/PD analysis and clinical
pharmacology trials designs.
Represents the Biometrics group on Development Sub-Teams, and plans and
coordinates Biometrics activities to ensure successful and timely completion
of assigned projects.
Develops statistical analysis plans, prepares data displays and as necessary
develops statistical programs to perform exploratory and sensitivity
analyses.
Authors the clinical study report. With help from senior statistical staff,
leads team members to complete the report. Responsible for seeing the report
through the review process.
Keeps abreast of new developments in statistics, drug development, and
regulatory guidance through literature review, workshop attendance, etc.
Participates in department and cross-functional initiatives aimed at
optimizing drug development process,
Requirements:
Ph.D. in statistics/biostatistics with at least 2 years of clinical trials
experience/ A Master's Degree in statistics/biostatistics with at least 5
years of clinical trials experience.
Experience with statistical software packages such as R/S-Plus and SAS.
Sound knowledge of theoretical and applied statistics.
Sound understanding of regulatory guidelines in a pharmaceutical research
setting.
Effective communication skills.
Effective team contributor.
THIS IS NOT A PROGRAMMING POSITION Senior Biostatisticians only
2) Senior Biostatistician
Prefer someone located in Overland KS but will consider 100% telecommute for
the right candidate
=Start date 5/17
6 month contract with option for extension
The Senior Biostatistician will develop statistical methods sections of
protocols and review case report forms (CRFs). Prepare analysis plans and
write specifications for analysis files, consistency checks, tables, and
figures. Communicate with clients regarding study protocol or statistical
analysis issues as they arise. Communicate with study team members regarding
study execution as it relates to timelines, data quality, and
interpretation of results. Interpret analyses and write statistical sections
of study reports.
RESPONSIBILITIES
Coordinate the development of analysis plans, table shells, programming and
table specifications, the production of tables, listings and figures, data
review and statistical analysis.
Perform protocol development, sample size calculation, protocol and CRF
review.
Advise data management staff on database design, validation checks and
critical data.
Write statistical sections of integrated reports.
Provide expert statistical input into and review of statistical deliverables
(i.e. analysis plans, table shells, programming and table specifications,
data review, tables, listings, figures and statistical sections for
integrated reports) and data management deliverables (i.e. database design,
validation checks and critical data).
Fulfill the Lead role for single complex studies or groups of studies.
Manage project budget and resource requirements. Understand the Scope of
Work, budget and quote assumptions, estimate the work completed, manage
scope, and provide revenue and resource forecasts for single studies.
Perform the review of RFPs and QIPs, prepare proposal text and attend bid
defense meetings.
Manage customer relationships and provide training and guidance to lower
level and new staff.
Qualifications
PhD or educational equivalent in biostatistics or related field and 5 year
relevant experience; Master's degree or educational equivalent in
biostatistics or related field and 8 years relevant experience
Familiarity with moderately complex statistical methods that apply to Phase
I-IV clinical trials
Strong working knowledge of SAS computing package
Familiarity with other statistical computing packages such as S+, SUDAAN,
StatXact
Pharmaceutical, drug development, biotech or CRO industry experience
Excellent written and oral communication skills including grammatical/
technical writing skills
Excellent attention and accuracy with details
Strong individual initiative, organization skills and multi-tasking ability.
Ability to lead and co-ordinate small teams
Maria Kardan
Sr. Placement Manager
National SAS Business Analytics & Clinical Practice
Experis - Formerly COMSYS
1600 Sawgrass Corp. Pkwy Suite 120
Sunrise FL 33323
T: +1 954 382 5628
F: +1 954 851 0987
C: +1 954 591 6116
M**********[email protected]
www.experis.com
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