Role: Project Statistician
*Develops or assists in the development of protocol designs, clinical plans,
and data analysis plans in collaboration with physicians, health outcomes
scientists.
*Ensure scientific review & validity of ECS work products.
*Maintain linkages to appropriate regional and global business and
statistics personnel.
*Responsible for researching, understanding, and summarizing new analytical
techniques when necessary
Advocate for PMR and ensure the scientific integrity of the work undertaken
by the ECS team.
* Actively support and promote a common approach to both regional and global
solutions
*Collaborate with statistical analysts to ensure that proposed analyses are
implementable, sufficient time is allowed for implementation and that all
necessary business partner input is obtained.
Capacity management and project execution
* Responsible for successful delivery of therapeutic area statistical work
products - on time, on budget and meeting quality and functional
expectations.
* Responsible for timely quality completion of monthly timesheets
* Responsible for giving input to the creation and maintenance of project
briefs relevant to therapeutic area of responsibility in consultation with
group leader and business partners. Responsible for developing and
maintaining study-level project plans for all assigned studies as a result
of agreed project briefs.
*Track deliverables for assigned studies and regularly report progress to
group leader and business partners. Agree any associated actions with group
leader and business partners in line with ECOS Shared Service Offering
expectations.
Statistical Trial Design and Analysis
* Operate in collaboration with medical personnel, health outcomes
personnel, and other relevant individuals to provide input on study
protocol, design studies and write protocols / study descriptors for the
conduct of each study.
* Assist in or be accountable for selecting statistical methods for data
analysis, authoring the corresponding sections of the protocol, and
conducting the actual analysis once a reporting database is created.
* Collaborate with data management in the planning and implementation of
data quality assurance plans.
* Maintain currency with respect to statistical methodology in order to
maintain proficiency in applying new and varied methods and to be competent
in justifying methods selected.
* Participate in peer-review work products from other statistical
colleagues.
Therapeutic Area Knowledge
* Understand disease states and relevant European competitive landscape in
order to enhance the level of business partner focus and collaboration and
to influence as a strong scientific contributor.
Regulatory Compliance
* Perform work in full compliance with assigned curriculum(s) and
responsible for following applicable corporate, medical, local, and
departmental policies, procedures, processes, and training.
Job Requirements:
* Excellent interpersonal communication skills and demonstrated effective
customer consultation
* Demonstrated teamwork and influencing skills
* Demonstrated technical knowledge and application, with working knowledge
of experimental design and statistics. Preferable to have experience in
phase IV clinical trials and/or observational research.
* Demonstrated problem solving, creativity and innovative (out-of-the-box)
thinking.
* Strong self-management skills with a focus on results for timely and
accurate completion of competing deliverables
* Business process expertise associated with critical activities (e.g.
scientific data disclosure)
* Understanding of the Medical and Health Outcomes functional groups.
* Proficient in the SAS programming language
* Fluent in English - both oral and written
* Work effectively within a regulated environment where documentation and
quality are essential
If you are interested in this position, please contact me for review of the
full specification. If you know of anyone to which this is applicable but
may not receive this email, please feel free to forward this email to
relevant persons.
Regards
Mathew Hogan
Senior Consultant
Pharmaceutical, Biometrics & CRO Division
1st IT People
Tel: +44 (0) 207 255 6665
Fax: +44 (0) 207 255 6656
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