OB TITLE: ASSOCIATE BIOSTATISTICS DIRECTOR (Ref.FW-10504)
LOCATION / AREA: Hampshire / near Basingstoke / near Southampton / near
Winchester / Basingstoke area / Basingstoke region / Southampton area /
Southampton region / Winchester area / Winchester region / M3 / Home
Counties / South / South-East
SUMMARY OF ROLE: This is a senior role for an experienced
Biostatistician, Ph.D preferred, to direct and drive the statistical
aspects of drug development programmes for a specialty pharmaceutical
provider.
COMPANY INFO: Our client is a global specialty pharmaceutical company
specialising in central nervous system (CNS), gastrointestinal (GI) and
renal disease therapies. It markets products to defined customer groups
(specialist doctors), targeting the US, Canada, France, Germany, Italy,
Spain, the Republic of Ireland and the UK, while covering other
significant pharmaceutical markets through regional distributors. Its R&D
focus is on late stage, lower risk projects in areas where the company has
commercial presence. Once a tiny office above a Hampshire shop, it is now
one of the world's fastest growing pharmaceutical companies, has completed
several successful acquisitions and mergers, and thrives on an operating
income of more than $446 million.
JOB ROLE:
Within the Clinical R & D Department of the Global Biometrics division,
you will participate in the activities related to all statistical aspects
of drug development. Reporting to the Vice President of Global Biometrics
or the Biostatistics Director, you will contribute to clinical program
design and regulatory strategy. You will be responsible for the
preparation of relevant components of clinical development plans,
protocols, statistical analysis plans, clinical study reports, and all
other relevant components of the Common Technical Document (or other
components as required per local regulatory requirements). Post-marketing
activities will include protocol development, analysis, and reporting of
clinical trial results, and providing support for publications, posters,
and safety reporting as needed to meet regulatory requirements.
MINIMUM REQUIREMENTS:
Minimum M.Sc. in Biostatistics or a closely related field essential.
5+ years of relevant pharmaceutical development experience.
Familiarity with complex statistical methods that apply to all phases of
clinical trials.
Strong SAS programming skills using SAS/base, SAS/stat, SAS/graph, and SAS
macro, a clear understanding of computerised data structures, and
knowledgeable in Windows-based computer systems/applications.
Must have a strong working knowledge of statistical methodology used in
the industry and statistical analysis plans, including the report outline,
mockup table and graph, data listing shells, and appendices.
Knowledge of the CTD.
Strong attention to detail and accuracy.
Ability to read, analyse and interpret complex technical documents.
Working knowledge of filing regulatory documents and complex statistical
methods applicable to all phases of clinical trial conduct.
Ability to present complex issues in oral and written form.
Strong attention to detail in composing and proofing materials,
establishing priorities, scheduling and meeting deadlines.
Ability to work in a fast paced environment and juggle multiple competing
tasks and demands.
Ability to work independently, take initiative and complete tasks to
deadlines.
Ability to effectively present information to senior management, public
groups, and other departments.
Demonstrated ability to work in a team environment.
Ability to communicate effectively upwards, downwards, and laterally
throughout an organisation.
UNIQUE BENEFITS: This is an outstanding opportunity for an experienced
biostatistician / statistician / biometrician to take on a role of key
influence within a dynamic, fast-moving organisation, offering a
stimulating work environment and the opportunity to contribute to advances
in global healthcare.
KEYWORDS: ASSOCIATE BIOSTATISTICS DIRECTOR / BIOSTATISTICS DIRECTOR /
BIOSTATISTICS MANAGER / SENIOR BIOSTATISTICS MANAGER / BIOSTATISTICIAN /
SENIOR BIOSTATISTICIAN / BIOSTATISTICS / STATISTICS / BIOLOGY / CLINICAL
STATISTICS / MEDICAL STATISTICS / MATHEMATICS / BIOMETRICS
If you think you fit the bill, email your CV to: Lawrence@fforde-
management.com, speak to Lawrence on (0044) (0)1273 722366 or write to us
at Curtis House, 34 Third Avenue, Hove BN3 2PD Fax: (0)44 (0)1273 325350.
If you prefer a different kind of role, call for a confidential chat about
your personal career needs.
Fforde is a niche recruitment agency specialising in the pharmaceutical,
clinical research and biotechnology sectors, priding itself on a glowing
reputation within the industry and a high-quality personalised service
dedicated to intelligent delivery. Explore our website for a peek at all
our enticing job opportunities. www.fforde-management.com
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