Principal Biostatistician
Company: Cytel Software Corporation
Location: Toledo
Posted on: May 27, 2023
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Job Description:
As Principal Biostatistician, adapt at utilizing advanced
statistical methods, you will support or lead one or more Phase
I-IV clinical studies, with a focus on Neurological DisordersYou
will contribute by:providing statistical support to clinical
studies, with a focus on Neurological Disorders (Multiple
Sclerosis, HIV, Alzheimers, Strokes, etc.);participating in the
development of study protocols, including participation in study
design discussions and sample size calculations;reviewing CRFs and
data review guidelines; developing statistical analysis plans
(SAPs), including analysis dataset and TLG
specifications;performing statistical analyses;interpreting
statistical results;preparing clinical study reports, including
integrated summaries for submissions;leading study activities when
called upon;utilizing your strong communication skills to present
and explain methodology and consequences of decisions in lay
terms;serving as a team player, with a willingness to go the extra
distance to get results, meet deadlines, etc.;being adaptable and
flexible when priorities changeWhat were looking for:Masters degree
in statistics or a related discipline. PhD strongly desired.5+
years supporting clinical trials in the Pharmaceutical or
Biotechnology industry. Experience working for a CRO strongly
desired.Experience in sample size calculation, protocol concept
development, protocol development, SAP and preparing clinical study
reports including integrated summaries for submissions.Knowledge
and implementation of advanced statistical methods.Good SAS
programming skills for QCing critical outputs, Efficacy/Safety
tables and working closely with Programmers. Knowledge of R
programming a plus.Strong knowledge ofICH
guidelines.Solidunderstanding & implementation of CDISC requirement
for regulatory submissions.Adept in ADaM specifications generation
and QC of datasets.Submissions experienceExperience working with
cross-functional teams, a Study Management Team (SMT) or similar
teams for different clients.Effective communicator: able to explain
methodology and consequences of decisions in lay terms.Team player;
willingness to go the extra distance to get results, meet
deadlines, etc.Ability to be flexible when priorities change and
deal with ambiguityWhats in it for you:You will have the
opportunity to play an integral role helping our clients and the
industry shape the future of drug developmentYou will be part of an
exciting new chapter in Cytels history with high growth and
opportunities to progress in Senior and Leadership positions within
the companyWork in an environment designed for an entrepreneurial
minded person with a lot of energy, ideas and courage for their
implementationWork with and leverage the best and brightest minds
in the industryRequiredPreferredJob IndustriesCustomer Service
Keywords: Cytel Software Corporation, Toledo , Principal Biostatistician, Other , Toledo, Ohio
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