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http://biotech.fyicenter.com/jobs/99896525_Senior_Biostatistician.html
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Date: 07-Jun-2007
Senior Biostatistician
Sr. Biostatistician General Summary: This position is responsible for
providing broad statistical sup****t, including study design, protocol
development, sample size justification, and exploratory analyses using
SAS in sup****t of clinical trials. Performs computer simulations to
promote the understanding and communication of trial data. Prepares
statistical analysis plans, generates statistical summary tables and
performs database integration for meta-analyses.
Duties and Responsibilities: Under minimal supervision perform the
following duties: - Develops scientifically sound clinical development
plans of a series of study designs and contribute to study design
section of each protocol. - Performs statistical modeling using
logistic regression, propensity score analysis, discriminant analysis,
and stepwise procedure. - Performs post-hoc analyses and relevant
exploratory analyses of clinical trial data for conference
presentation and manuscript submission. - Leads novel analytical
method, performs complex SAS programming and addresses all study
programming issues. - Provides quality review on statistical analysis
plan to ensure consistency with protocol and adequacy to meet
objectives defined in protocol. - Provides consultation to clinical
project team on any statistical issues related to the trial conduct. -
Provides consultation on the statistical modeling and proposes
processes to expedite the re****ting process. - Interacts proactively
with internal functional groups to expedite the process of locking a
clean database and the analysis process for final unblinding. -
Sup****ts the external clients (such as FDA, Investigators, Vendors) on
project related statistical issues. - Generates statistical summary
tables and re****ts using SAS for exploratory post-hoc and meta-
analyses. - Designs, tests, performs quality control, implements and
do***ents databases for meta- analyses. - Handles complex SAS
programming issues independently and performs data integration for
meta-analyses.
Minimum Education & Experience: - Ph.D. or Masters of Science in
Biostatistics or equivalent is required. - The ideal candidate will
have 4-8 years of experience in clinical research and /or SAS
programming in pharmaceutical/biotechnology/device industry.
Working Conditions: A general office environment that includes some
minimal travels (approximately 15%) to hospital settings and/or
professional meetings. Potential exposure to blood borne pathogens and
other potentially infectious materials.
Competency Expectations: - Excellent analytical skills, with the
ability to process scientific and medical data, Must possess the
ability to work and make guided independent decisions, understand
basic medical information. - Superb knowledge of SAS programming & EDC
is required. - Expertise in manipulating and analyzing SAS data. -
Ability to identify data issues, present problems, and implement
solutions. - Capability to communicate technical concepts clearly,
concisely, and understandably to non-statistical colleagues. - Good
leader****p, organizational, and time management skills, with the
ability to multi-task. - Familiarity with clinical trial design and
analysis activities and basic knowledge of regulatory guidelines (FDA/
CFR, EN540/GCP) is critical. - Possesses the ability to work with
minimal supervision, and must have strong interpersonal communication
and presentation skills. - Works collaboratively across cross-
functional teams.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
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