職位詳情

Statistical Analysis
?Serve as statistician forresearch studies..
?Participate in orcontributes to protocol development （including study design, sample size calculation, randomization, andstatistical analysis
methodologies）, case report form design anddata collection.
? Interact with clients as key contact with regard to statistical issues.
?AuthorStatistical Analysis Plans andStatistical Analysis Reports.
?Develop statistical programs fordata listing, summary tables, andtrial
figures.
?Prepare datasets foranalysis by merging files, creating analysis variables,
editing data, anddeveloping documentation.
?Promote good statistical practice forthe support of sound scientific
judgments.
?Ensure trial documentations comply with Totrial guidelines.
Relationship Management
? Integrate ICH andFDA guidelines in designing analysis. Interacts with
medical writers forprotocol development andreport writing.
?Design efficient study andsample size estimation under client’s budget
consideration.
?Defence of study design andanalysis methodologies at the regulatory authorities inspection.
Additional Tasks
?Ensure tasks are completed anddelivered within scheduled andagreed
timeline.
?Maintain confidential information.
?May provide trainings to non-statistical peers with regard to statistical methodologies.
Skills
?Work effectively, precisely according to SOPs andregulations.
?Computer competency of Microsoft Office including ACCESS, Internet,
FoxPro, SPSS andSAS.
?Excellent organizational, communication, andstatistical analysis skills. ?Ability to communicate in English.
?Detail oriented.
?Teamwork spirit, communication skill andinterpersonal skills.
?Problem solving andmulti-task capability.
?Comply with regulations andICH-GCP andTotrial guidelines.
?Familiar with clinical trial statistical analysis process.
?Solid knowledge of experimental design, descriptive andinferential statistics
both theoretically as well as applied in clinical trials.
Education
?masterdegree orabove in statistics, mathematics orclosely related field.
Language Skills
?Ability to communicate in English.
Minimum Work Experience
?Over 2 years’ experience in statistical analysis orthe equivalent of education,
training orexperience.
?Ability to analyze data andsummarize findings andconclusions effectively in appropriate tabular, graphic andwritten formats.
?Ability to establish andmaintain effective working relationships with
co-workers, managers andclients.
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工作地點(diǎn)
無錫惠山區(qū)煌途醫(yī)藥（無錫）有限公司1719-8