- Providingstatistical support to clinicalstudies
- Participating in the development ofstudy protocols including participation in study design discussionsand sample size calculations
- Reviewing CRFs anddata review guidelines; developing statistical analysis plans(SAPs) including analysis dataset and TLGspecifications
- Performing statistical analysesand interpreting statistical results
- Preparingclinical study reports including integrated summaries forsubmissions
- Utilizing your strong communicationskills to present and explain the methodology and consequences ofdecisions.
- Masters degree instatistics or a related discipline. Ph.D. stronglydesired.
- 8 years supporting clinical trials inthe Pharmaceutical or Biotechnologyindustry.
- Experience working for a CRO isstrongly desired.
- Experience in sample sizecalculation protocol concept development protocol development SAPand preparing clinical study reports including integrated summariesfor submissions.
- Good SAS programming skillsfor QCing critical outputs Efficacy/Safety tables and workingclosely with Programmers. Knowledge of R programming is aplus.
- Solid understanding implementation ofCDISC requirements for regulatorysubmissions.
- Adept in ADaM specificationsgeneration and QC of datasets
- The ability tobuild strong external internal relationships and motivate aregional or global team.
- Very effectivecommunicator: able to explain methodology and consequences ofdecisions in lay terms.
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Principal Biostatistician - London, United Kingdom - Lifelancer
Description
Our Senior Biostatisticians perform adhoc orexploratory analyses to support submission or Health AuthorityQuestions. Having exposure to regulatory work experience is a bonusfor example if you understand the regulatory questions andtranslating them to statistical problems collaborating effectivelywith clinical and regulatory colleagues. Supporting mediumcomplexity clinical trials (starting from Design to Archivalexperience) and supporting some projectlevelactivities.
As a Principal Biostatisticianyour responsibilities willinclude:
Tobe successful in this position you willhave:
Please usethe below link for job application and quickerresponse.
RemoteWork :
No
