Senior Statistician
Ref: 00364
This is an excellent opportunity for an experienced Clinical Statistician to join
a company that is committed to providing high quality solutions to the clinical
research community via their EDC products and Data Management and
Biostatistical services. They achieved Oracle Partner status in 2004 and
provide high level consultancy and training services for partners and
customers. They require a Senior Statistician at their office in Raleigh, North
Carolina.
JOB ROLE: The Senior Statistician is responsible for the successful
coordination and execution of all activities related to the design, analysis and
reporting of clinical data across multiple therapeutic areas and phases of
development.
PRINCIPAL RESPONSIBILITIES include:
Providing a flexible, expert consultancy service on all aspects of
statistics within the clinical trials arena
Authoring and reviewing Statistical Analysis Plans, including
preparation of table shells
Programming in SAS, all hypothesis tests and tables/figures/listings
as necessary to meet project standards and timelines
Reviewing (QC and QA) work of Statistical Programmers and junior
Statisticians and providing senior statistical review of final deliverables
Deriving and reporting PK/PD results via non linear regression
techniques
Providing input into proposals and track study budgets as
requested
Providing statistical leadership and business development support
Attend bid defence and company presentations in conjunction
with BD
Providing consultancy on investigator led studies and publications
Assisting in SOP development
Providing input into the maintenance and improvement of
processes as appropriate
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Minimum of an MS degree along with 5 years of direct Clinical
Trials Statistical experience including both internal and external responsibilities.
Essential experience:
Programming tables, figures, and listings and performing statistical
analysis in SAS
Direct development of Statistical Analysis Plans
Development and review of protocols
Preferred experience:
Support of international regulatory filings (ISS/ISE/CTD)
CDISC standards
PK/PD analysis and reporting
Technical expertise to support all phases of clinical trials in many
therapeutic areas to suit the CRO environment.
SKILLS & PERSONAL ATTRIBUTES:
Excellent communication skills
Strong attention to detail.
Flexibility and a proactive approach are essential.
Team worker
The ability to lead a multinational analysis meeting or
teleconference
BENEFITS OF THE ROLE: This is an outstanding opportunity to join a fast
growing and exciting global company where you can make a major contribution
to the project and company success. There are excellent career development
prospects and you can earn a very competitive salary commensurate to the
role plus enjoy the companys excellent benefits.
Fforde is a uniquely specialised recruitment agency/business for the
pharmaceutical, clinical research and biotechnology sectors. For applications
please email your CV to: [log in to unmask] or speak to our
specialist consultant, Nando Rodriguez on +1 212 520 8323 who will be
pleased to give you further information and advice on your personal career
needs. Visit our website and see all our job opportunities at www.fforde-
management.com
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