A world leading pharmaceuctical company seeking an experienced
Biostatistican to take control of specific Thereputical areas and projects.
Leading other Biostatisticians and SAS programmers. With minimul direction
you with have the atonomy and skills to drive these projects forward with
little or no supervision. 

Intial 6 month contract plus relocation assistance and the expectance of
long term work on offer. With top market rates and the obvious benefits of
Swiss taxation this role is extermely attractive so please apply  your
interest immediately to ensure consideration

Please contact me Gavin O'Neill Stelfox Recruitment on 01273 727 930 or via
e-mail [log in to unmask] 

PURPOSE OF THE ROLE

May manage a small number of Biostatisticians and/or statistical programmers
focused
on a limited number of Therapeutic areas. With limited direction, provide
statistical input
for statistically complex protocol development. With limited direction,
write statistical
analysis plans & perform statistical analyse for statistically complex
clinical trials.
Independently provide statistical input for statistically routine protocol
development. Independently write statistical analysis plans and perform
statistical
analysis for statistically routine clinical trials. With limited direction,
participate in
departmental standardization efforts.

KEY TASKS & RESPONSIBILITIES
· Statistically mentor Biostatisticians and programmers in relevant
therapeutic areas
· Keep abreast of statistical developments
· Research and write statistical conventions
· Develop statistical standards for clinical development programs
· Validate tables & derived listings as required
· Ensure that programming and validation is performed
· Independently provide statistical input for statistically routine protocol/CRF
development and query checks
· Write analysis plans for statistically routine clinical trials
· Write analysis plans for statistically complex trials as well as for
integrated safety
& efficacy summaries
· Analysis plan written include the most appropriate statistical methodology
& data
presentations
· Review analysis plans for statistically routine clinical trials
· Analyze statistically complex clinical trials
· Review analysis results for statistically routine clinical trials
· Write accurate, logical, clear, concise, thorough & objective statistical
methods
sections for statistically routine integrated final reports
· Review statistically integrated draft reports ensuring the accuracy of the
statistics
as well as their interpretation
· Review statistical method sections & the interpretation of results written for
statistically routine clinical trials
· Independently perform routine statistical analyses for manuscripts
· Perform complex statistical analyses for manuscripts
· Review manuscripts, perform complex statistical analyses for manuscripts
· Review manuscripts for accurate statistic & statistical interpretation
· Understand manuscripts for accurate statistical interpretation
· Understand & follow all statistical programming SOPs as well as any other
relevant SOP
· Write statistical SOPs as required
· Review statistical & statistical programming SOPs
· Provide input into general standardization efforts
· Develop routine 6 complex statistical standards
· Provide direction to biostatisticians & statistical programmers in the
standardization area
· Represent the employer regarding statistical issues with regulatory agencies
· Provide input into the determination of the AOP for the department as required
· Provide leadership to non-statistical colleagues with statistical issues
· Lead process improvement teams as required
EDUCATION/LANGUAGES
· PhD or MSc
· English fluency
PROFESSIONAL SKILLS & EXPERIENCE
· 5 - 8 years pharmaceutical/Biotech experience
· SAS experience & highly proficient in SAS statistical procedures
· Extensive knowledge routine statistical methodology
· Fundamental knowledge of relevant clinical areas
· Knowledge of the statistical & clinical regulatory guidelines/requirements
specific
to relevant therapeutic areas & their implications for statistical analysis
PERSONAL SKILLS & COMPETENCIES
· Excellent communication skills
· Self directed
· Exhibits initiative & sensitivity in conflict resolution
· Recognized as a problem solver who focuses on facts
· Consistently makes informed decisions seeking guidance if necessary