Associate Principal Biostatistician
Company: Premier Research
Location: Quincy
Posted on: February 16, 2021
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Job Description:
Wish you were here? Recognised recently as a Top CRO by Life
Science Leader, Premier Research is a medium sized, full service,
global CRO with circa 1,500 employees worldwide, perfectly
positioned to be big enough to help, yet small enough to care. We
have an aspiring and empowering culture and strive to work globally
as #oneteam. Premier helps highly innovative bio-pharmaceutical and
medical device companies transform life-changing ideas into
reality. We take on the most challenging areas of study, with a
special focus on unmet needs in such areas as Oncology, Neurology,
Paediatrics, Rare Diseases and Medical Devices, supporting the
needs of smaller Pharmaceutical organisations and Biotech
companies. There is real opportunity to work across multiple
clients on a variety of unique and interesting studies including
integrated analyses and regulatory submissions. Continued growth
means we are excited to have the chance to add a Senior / Lead
Biostatistician to our Biostatistics team. We can consider office,
home based or a mix of the two across many locations. This is a
great opportunity to advance your skills (such as lead studies, IND
submissions and high-level consulting work) and grow with a company
who recognizes you as an individual in an aspiring, caring and
empowering culture. Interested to join a forward thinking, family
feel company which offers real opportunity to add value and help
improve patient lives whilst having fun? And at Premier Research,
its not all work, work, work - across our offices, there are always
numerous social & extra-curricular events to get involved in should
you so wish, whether it be lunch-and-learns, summer picnics,
charity fund raising events, language lessons, or fun contests! If
we hear from you, youll hear from us! As a Senior level
Biostatistician, youll have the opportunity to represent Premier
Research as our primary contact with our sponsors, applying
knowledge of statistics to independently provide statistical
consulting, assist with study design and protocol development, and
performs statistical analysis of clinical trials. Youll review
project related documents, prepare statistical analysis plans
(SAPs) and statistical reports. You will also develop analysis data
specifications, create analysis datasets, Tables, Listings and
Graphs (TLG) of clinical trial data using SAS. In this role, youll
perform quality control of TLGs and derived data sets created by
others, as well as develop and validate SAS programs, macros, and
utility tools. Youll also have the unique opportunity to work on
NDA submissions-to engage with studies at the program
levelpreparing Clinical Summaries of Safety (ISS) and Efficacy
(ISE). What youll be doing: Independently utilize your respected
expertise to provide statistical consulting Prepare statistical
sections of protocols, performing sample size and power calculation
for studies, and create randomization schedule per study design and
relevant specifications Review protocols, case report forms (CRFs),
data management plans, data specifications and other related study
documents Develop statistical analysis plans (SAP) in accordance
with the protocols and SAS programs to create statistical models
and complete statistical analyses Support integrated summaries of
safety and efficacy (ISS and ISE) for regulatory submissions
Independently prepare analysis data specifications Develop SAS
programs to create derived variables and analysis data sets and
computer programs to generate listings, tables, and graphs using
SAS Perform quality control of analysis data and TLGs Review and
provide input in interpreting analysis result to clinical study
report You'll Need this Background to be Considered: Advanced
degree (MS or PhD, or equivalent) in statistics or closely related
field along with 4-6 years (or 3-5 years for PhD) of direct
experience of clinical trials design and regulatory knowledge and
analysis with advanced SAS programming experience Proven knowledge
of CDISC standards and application of those standards to projects;
demonstrated working knowledge of advanced SAS macro development
and code generation/management algorithms Ability to effectively
communicate with others on the project team and in the department;
strong interpersonal communication skills Detail oriented, well
organized with the ability to work on several projects
simultaneously Excellent team player, collaborative and maintains a
positive, results-orientated work environment Accountable,
dependable and demonstrates strong commitment to the role Is
customer service focused in approach to work, both internally and
externally
Keywords: Premier Research, Quincy , Associate Principal Biostatistician, Other , Quincy, Massachusetts
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