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Principal Statistician (Pharmacokinetics)(m/w/x)
Conducting statistical analysis for clinical trials, reviewing study protocols and deliverables. Expert SAS programming and CDISC ADaM standard knowledge required. Mentoring junior staff, client communication focus.
Requirements
- MSc in Statistics or equivalent
- Full working proficiency in English
- Expert knowledge of statistical principles
- Expert knowledge of SAS programming
- Expert knowledge of CDISC ADaM standard
- Expert knowledge of pharmacokinetics principles
- Expert knowledge of Phoenix WinNonlin and NLME
- Expert knowledge of relevant regulations
- Ability to apply advanced statistical techniques
- Ability to consult with clinical investigators
- Strong presentation and communication skills
Tasks
- Serve as a communication link for project teams and clients.
- Conduct statistical analysis for clinical trials.
- Develop and review study protocols and analysis plans.
- Review statistical deliverables like tables and datasets.
- Conduct training for statisticians and SAS programmers.
- Prepare for and attend study audits related to statistics.
- Participate in follow-up for internal and external audits.
- Provide input to standard operating procedures for Biostatistics.
- Liaise with data management on statistical data issues.
- Participate in bid defense and kick-off meetings.
- Lead teams of SAS programmers and statisticians.
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- Phoenix WinNonlin
- NLME
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Principal Statistician (Pharmacokinetics)(m/w/x)
Conducting statistical analysis for clinical trials, reviewing study protocols and deliverables. Expert SAS programming and CDISC ADaM standard knowledge required. Mentoring junior staff, client communication focus.
Requirements
- MSc in Statistics or equivalent
- Full working proficiency in English
- Expert knowledge of statistical principles
- Expert knowledge of SAS programming
- Expert knowledge of CDISC ADaM standard
- Expert knowledge of pharmacokinetics principles
- Expert knowledge of Phoenix WinNonlin and NLME
- Expert knowledge of relevant regulations
- Ability to apply advanced statistical techniques
- Ability to consult with clinical investigators
- Strong presentation and communication skills
Tasks
- Serve as a communication link for project teams and clients.
- Conduct statistical analysis for clinical trials.
- Develop and review study protocols and analysis plans.
- Review statistical deliverables like tables and datasets.
- Conduct training for statisticians and SAS programmers.
- Prepare for and attend study audits related to statistics.
- Participate in follow-up for internal and external audits.
- Provide input to standard operating procedures for Biostatistics.
- Liaise with data management on statistical data issues.
- Participate in bid defense and kick-off meetings.
- Lead teams of SAS programmers and statisticians.
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- Phoenix WinNonlin
- NLME
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
PSI CRO
Industry
Pharmaceuticals
Description
The company is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation.
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