Work With GSG:
We are currently looking for qualified person with following credentials.
Proposed Duties:
Provide statistical input for protocols including sample size estimation and appropriate statistical methodology.
Assist in development and review of statistical analysis plans (including TLG shells)
Prepare and review programming specifications used in creating analysis datasets (ADaM), tables, listings, and figures.
Perform statistical analyses for clinical trials data.
Validate computer programs and perform quality checks for statistical output.
Communicate with clients on statistical issues and project status.
Understand, implement and support CDISC (ADaM and SDTM) and other regulatory standards.
Perform Ad-Hoc requests for journal publications or exploratory Ad-hoc analysis
Produce special reports to comply with regulatory requests
Perform ISS/ISE in support of sponsor
Program high quality tables, listings, patient profiles, derived data sets, figures, and analysis to support safety, efficacy, and pharmacokinetic assessments during clinical development
Qualifications:
PhD or Masters Degree in statistics, biostatistics or a closely related field.
2+ years clinical trials experience as a biostatistician in a pharmaceutical, biotech or CRO environment.
Knowledge of statistical concepts, strong statistical and SAS programming skills, including data manipulation and statistical analysis procedures.
Knowledge of regulatory standards including CDISC
Must have experience with Word, Excel, and PowerPoint.
Strong interpersonal, organizational, and communication skills are required.
Detail-oriented, team-oriented, and self-motivated, and be able to work on multiple projects simultaneously.
Understand the nature of meeting the timeline
If you have above skills and would like to join our team, please send us your resume to chaeyong.chang
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