Statistician (Contract)
Ref: 14103
This is an exceptional opportunity for a Statistician with solid experience
working in international drug development to join a world class organisation
that now ranks as the fastest-growing among the UK's top 50 pharmaceutical
companies. They require a Statistician in a contract role for 12 months at
their office in Central London.
JOB ROLE: The Statistician will provide programme-level statistical expertise
by designing, analysing and interpreting clinical studies and programmes;
standardising study design, analysis methodology and presentations and
overseeing external vendors providing statistical services to achieve quality,
timely, cost-effective study deliverables.
PRINCIPAL RESPONSIBILITIES include:
• Representing the statistics function in support of clinical studies
led from the US or EU.
• Providing statistical input to feasibility assessments, development
and submission plans, and defence of regulatory submissions.
• Providing accurate, statistically appropriate outputs in protocols,
statistical analysis plans, study reports and regulatory submission documents.
• Implementing project level database, analysis and reporting
standards.
• Planning and directing study-level analysis and reporting activities.
• Identifying study-level vendor requirements and participating in
vendor evaluation/selection.
• Providing technical oversight of statistical activities of external
vendors.
• Supporting standards and process improvements.
• Complying with all applicable regulatory requirements and Company
standards and procedures.
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
• PhD or MS in statistics or biostatistics with significant relevant
experience.
• Knowledge of clinical study designs, common analysis methods,
descriptive and inferential statistics, and data presentation practices.
• Good understanding of clinical drug development process and
documents.
• Knowledge of FDA and ICH regulations and industry standards
applicable to the design and analysis of clinical trials.
• Good knowledge of statistical programming languages (including
SAS), software, techniques, and processes.
• Working knowledge of UNIX operating systems, and common
software products and technologies used in conjunction with SAS.
• Good oral and written communications skills.
BENEFITS OF THE ROLE: This is one of the fastest growing pharmaceutical
companies in the industry that values its staff and provides the framework to
bring out the best in everyone. You can earn an excellent remuneration for
this role along with the advantages of a central London lifestyle.
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, Chris Brown on +44 (0)1273 222967 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
KEY WORDS: Statistician, Statistics, Biostatistics, Clinical Development,
Clinical Trials, Clinical Studies, Clinical Study Design, ICH, FDA, SAS, Statistical
Programming, UNIX Operating Systems, Project Management, Pharmaceutical,
PhD, MS
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