Working for a Top 15 Pharmaceuticals Company, the fastest growing in their
field; A company that take care to provide better health for individuals and
strive to create a scientific progress in medicine by developing safe,
effective and innovative pharmaceutical products.
Located in London, this is an opportunity to work with a company that rarely
recruits externally and takes real pride in it's employee's achievements,
this is and excellent opportunity to take the next step in your career.
The purpose of this position is to provide program/therapeutic
area/development phase statistical expertise and leadership by:
∑ Designing, analyzing and interpreting clinical studies and
programs (US and EU).
∑ Providing strategic statistical input for feasibility assessments,
development plans, cross-study analyses and regulatory submissions.
∑ Standardizing study design, analysis methodology and presentations
to maximize global data integratability and inter-program efficiency.
∑ Leveraging external vendors providing statistical services to
achieve quality, timely, cost-effective study deliverables.
∑ Independently representing Statistics function in interactions
with regulatory authorities.
DUTIES AND RESPONSIBILITIES
∑ Represent the statistics function on global teams in support of
clinical studies and programs led from either the US or EU.
∑ Provide strategic statistical input to feasibility assessments,
development and submission plans, and defence of regulatory submissions.
∑ Provide accurate, statistically appropriate outputs included in
protocols, statistical analysis plans, study reports and regulatory
∑ Oversee definition and implementation of project level database
(including derived database), analysis and reporting standards.
∑ Plan and direct program-level analysis and reporting activities
including work of other statisticians and programmers.
∑ Identify program-level vendor requirements and participate in
the evaluation/selection of BDM vendors. Provide technical oversight of
statistical activities of external vendors to ensure timeliness and quality
of analysis data and statistical outputs. Review and approve key statistical
∑ Identify and interact with external statistical experts for
issues related to design, methodology and results.
∑ Anticipate and communicate resource and quality issues that may
impact deliverables or timelines. Propose and implement solutions. Escalate
issues to management as appropriate.
∑ Increase efficiency of the Statistics function through
development of standard analysis methodology, data presentations and sharing
of best practices. Lead the implementation of such standards and process
∑ Monitor and contribute to industry advances in statistical
methods to optimize study designs and statistical analyses.
∑ Comply with all applicable regulatory requirements, standards
∑ Perform other duties as assigned
∑ MS in statistics or biostatistics and 10 years of relevant
pharmaceutical industry experience, or PhD in statistics or biostatistics
with minimum of 7 years of relevant pharmaceutical industry experience.
∑ Experience on at least two global projects and at least two
∑ Advanced knowledge of clinical study designs, common analysis
methods, descriptive and inferential statistics, and data presentation
∑ Advanced knowledge of the pharmaceutical industry including
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.
∑ Demonstrated success independently representing Statistics
function in interactions with FDA including end of Phase II, pre-NDA
meetings or advisory committee meetings.
∑ 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 (e.g., Microsoft Office“ products).
Pharmaceutical, Healthcare & CRO division
1st Pharma People
"A Division of 1st IT People"
Tel: +44 (0) 207 255 6665
Fax: +44 (0) 207 255 6656
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