Senior/Principal Biostatistician - FSP (Remote)
Company: Cytel Software Corporation
Posted on: August 5, 2022
Cytel provides unrivaled biostatistics and operations research
knowledge to our customers in the life sciences industries in the
form of both software and services. At Cytel, we work hard to
create successful careers with significant professional growth for
our employees, as a result of which they work hard to make Cytel
successful. Cytel is a place where talent, experience and integrity
come together to advance the state of drug development. In this
role you will join our FSP department and will for our client, one
of the top pharmaceutical companies. As Senior/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 Disorders You will contribute by:
- providing statistical support to clinical studies, with a focus
on Neurological Disorders (Multiple Sclerosis, HIV, Alzheimer s,
- participating in the development of study protocols, including
participation in study design discussions and sample size
- reviewing CRFs and data review guidelines; developing
statistical analysis plans (SAPs), including analysis dataset and
- 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
- 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 change What we re
- Master s degree in statistics or a related discipline. PhD
- 5+ years supporting clinical trials in the Pharmaceutical or
Biotechnology industry. Experience working for a CRO strongly
- 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
- Good SAS programming skills for QCing critical outputs,
Efficacy/Safety tables and working closely with Programmers.
Knowledge of R programming a plus.
- Strong knowledge of ICH guidelines.
- Solid understanding & implementation of CDISC requirement for
- Adept in ADaM specifications generation and QC of
- Submissions experience
- Experience 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
ambiguity What s 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
- You will be part of an exciting new chapter in Cytel s history
with high growth and opportunities to progress in Senior and
Leadership positions within the company
- Work in an environment designed for an entrepreneurial minded
person with a lot of energy, ideas and courage for their
- Work with and leverage the best and brightest minds in the
Keywords: Cytel Software Corporation, Huntsville , Senior/Principal Biostatistician - FSP (Remote), Other , Huntsville, Alabama
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