Our client company is a global biotechnology firm; they are driven by a
desire to attain scientific excellence in order to achieve new standards of
care. They currently have over twenty products in clinical development
addressing a variety of key medical needs. They operate in over 70 countries
and have over 3,000 employees worldwide.
Our client is now looking for an ambitious and determined individual to take
on the position of Senior Biostatistician within their Research and
Development team in Massachusetts, US.
This role will offer the individual an exciting and rewarding career and the
chance to be a part of a leading team of experts within the biostatistics
field.
The responsibilities for this position will include, providing statistical
support as assigned by the Manager, serve as primary biostatistician on one
or more projects, to participate in the development of study protocols
including participation in study design discussions and to review CRFs and
data edits. They will also develop statistical analysis plans including
analysis file and report specifications and perform statistical analyses,
interpret statistical results, and prepare clinical study reports including
integrated summaries for submissions.
The essential functions for the role are:
·Participate in protocol development ensuring that the design meets the
objectives and is optimal within the imposed constraints. Perform sample
size estimates and/or power calculations to evaluate the costs of various
design scenarios. Review CRFs and data edits. Perform sample size estimates
and/or power calculations. Propose methods for statistical analysis and
prepares statistical section of protocols.
·Prepare randomization schedule.
·Prepare statistical analysis plans (including specifications for analysis
files and report tables); perform the analyses of the clinical data, and
adherence to project conventions. Is able to analyze complex data issues and
readjust analysis plans according to statistical considerations.
·Lead study team in the review and discussion of analysis plan, report plan,
and results.
·Understand and utilizes those aspects of computer science necessary for
efficient data management and statistical analysis. Propose and review
procedures relating to computer usage. Conduct complex statistical analysis
utilizing SASâ and other statistical software packages, as required.
·Interpret statistical results and presents findings in an appropriate
format. Prepare the statistical methods and results sections of clinical
study reports ensuring that graphical and tabular summaries are clear and
concise and that the objectives of the study are addressed. May present
statistical results to non-statisticians for clinical interpretation.·
Maintain project files ensuring adequate, clear documentation of data
sources, management and analysis.
Additional Functions for the position include:
·Provide general consultation and training to appropriate Company personnel,
usually on an informal, as-needed basis.
·Maintain proficiency in statistics and regulatory issues through training
courses, participation in appropriate societies, review of professional
literature, industry and academic contacts, etc.
·Demonstrate excellent leadership and communication skills.
·Possess knowledge of regulations and follow appropriately.
·Ability to work independently on routine assignments, under supervision on
new assignments.
·Ability to identify and resolve areas of concerns. Work with others as
necessary.
·Ability to maintain confidentiality.
·Demonstrate strong organizational skills, including the ability to
prioritize workload.
The qualifications for the role include:
·MS or PhD in Biostatistics/Statistics or equivalent.
·MS with 4 years or PhD with 2 years or more working on clinical trials
·IND/BLA/NDA/MAA experience desired but not essential.
Technical Skills which are required are:
·Thorough understanding of statistical principles and clinical trial
methodology with the ability to practice and implement them. Ability to
provide solutions to a variety of technical problems of moderate scope and
complexity.
·Some knowledge of medical/biological terminology and clinical trial designs
in relevant therapeutic areas.
·Attentive to detail.
·Excellent written and oral communication skills including
grammatical/technical writing skills.
·Conversant with SAS programming, and knowledge of SAS procedures and other
statistical software.
·Working knowledge of regulatory guidelines relating to statistical
analysis, study reports and statistical components of regulatory
submissions.
The successful candidate must also be an effective communicator with the
ability to explain methodology and consequences of decisions in lay terms.
be an effective team player; with willingness to go the extra distance to
get results and meet deadlines, etc. They must also be able to be flexible
when priorities change and able to deal with ambiguity
If you feel as if you have the sufficient experience and qualifications to
take on this exciting role, within a forward thinking and dynamic company
then please send us a copy of your most recent CV to [log in to unmask]
<mailto:[log in to unmask]> quoting the reference number
NEC.0002.BIO.AC.
Abbi Cohen | Project Co-ordinator | AspirionPharma
Direct Line + 44 (0) 208 304 6538
Fax + 44 (0) 208 304 6549
Mobile + 44 (0) 792 119 7221
<mailto:[log in to unmask]> abbi
<mailto:[log in to unmask]> @aspirionpharma.com
AspirionPharma is part of the Aspirion Group of Companies
<http://www.aspiriongroup.com> www.aspiriongroup.com
The information in the e-mail is confidential and may be legally privileged.
It is intended solely for the addressee. Access to this e-mail by anyone
else is unauthorised. If you are not the intended recipient, any disclosure,
copying, distribution or any action taken or omitted to be taken in reliance
on it, is prohibited and may be unlawful. When addressed to our clients any
opinions or advice contained in this e-mail are subject to Aspirion Ltd
Terms of Business.
|