Dear All,
I have an interim opportunity, 6-12 months, to work for a Bio-Pharmaceutical organisation in mainland Europe.
The role will have competitive daily rates, free accommodation and funds for a free flight every quarter.
JD attached.
Interested parties please apply to Mr Moin Din, details below.
Kind Regards
Moin Din
RSA Interims
01707 228603(T)
07930 396746(M)
[log in to unmask](E)
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BIOMETRICS MSU
Geneva
Job description N
r
Responsibility
Requirements:
PhD in Biostatistics or Statistics : 2 years pharmaceutical/biotechnology or other relevant experience.
MS in Biostatistics or Statistics : 5 years pharmaceutical/biotechnology or other relevant experience.
Working SAS knowledge and proficient in SAS statistical procedures.
Excellent communication skills.
Protocol/CRF Development
With limited direction provide statistical input for statistically routine protocol/CRF development and query checks.
With direction, provide statistical input for statistically complex protocol/CRF development (e.g., design; appropriate collection of observations in order to satisfy objectives; sample size estimation for the most efficient and practical design; patient randomization; accurate, logical, clear, concise and thorough evaluation of results section; effective CRF specifications to collect data specified in the protocol) and query checks. .
Analysis Plans
With limited direction, write analysis plans for statistically routine clinical trials.
With direction, write analysis plans for statistically complex clinical trials as well as for integrated safety and efficacy summaries.
Analysis plans written include the most appropriate statistical methodology and data presentations.
Statistical Analyses
With limited direction analyze statistically routine clinical trials.
With direction, analyze statistically complex clinical trials.
Integrated Reports
With limited direction write accurate, logical, clear, concise, thorough and objective statistical methods sections for statistically routine integrated final reports.
With direction, write accurate, logical, clear, concise, thorough and objective statistical methods sections for statistically complex integrated final reports.
Review statistically routine or complex integrated draft reports ensuring the accuracy of the statistics as well as their interpretation.
Regulatory Submissions/Contacts
Applicable knowledge of ICH statistical and clinical report guidelines applying relevant guidelines
as appropriate.
With direction, participate in Serono regarding statistical iinteractions with regulatory agencies.
With extensive direction, understand and interpret the statistical aspects of regulatory agency requests.
With extensive direction, develop responses to regulatory agency requests that maintain perspective and are within the appropriate context.
Manuscripts
With limited direction, perform routine statistical analyses for manuscripts.
With direction, perform complex statistical analyses for manuscripts.
Review manuscripts for accurate statistics and statistical interpretation.
Statistical Knowledge
Extensive knowledge of, and with limited direction, application of routine statistical methodology.
Fundamental knowledge of, and with direction, application of complex statistical methodology.
Keep abreast of statistical developments.
Clinical Knowledge
Familiarization with relevant clinical areas.
Problem Solving
Exhibits routine and complex problem solving skills.
With extensive direction, provide solutions for complex issues presenting alternatives and identifying the best solution.
Programming
Validate tables and derived listings as required.
SOPs
Understand and follow all statistical and statistical programming SOPs as well as any other
relevant SOP.
With direction, write statistical SOPs as required.
Standardization
With direction, provide input into general standardization efforts (e.g., CRFs, query checks, statistical methodology, standard statistical programs, data presentations).
Communication
With direction, communicate routine and complex statistical concepts and results to non-statistical internal and external colleagues in a clear, concise, focused and articulate manner.
With direction, function as the statistical primary contact with CROs for studies that are outsourced.
With direction, ensure the accuracy and timeliness of the CROs analysis alerting management to any unforeseen circumstances.
Leadership
Provide leadership to non-statistical colleagues with statistical issues.
Teams
With limited direction, participate effectively on teams for statistically routine clinical trials.
With direction, participate effectively on teams for statistically complex clinical trials.
Time and Work Management
Produce assigned work within the timelines provided ensuring deadlines are met.
Balance concurrent tasks and priorities.
N Statistical Programmer/ NII
RSA Interims
Assign the Best
Direct Line: 01707 228603
Mobile: 07930 396746
email: [log in to unmask]
For further information on RSA Interims see our website: http://www.rsainterims.com
For RSA's current vacancy list please see www.rsajobs.com
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