AD Biostatistical Consultant@Theravance Bi9pharma US, Inc.
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Over fifteen years as a professional clinical biostatistician in pharmaceutical industry.
Extensive FDA/EMA submission experiences for clinical studies (Phase I-IV/ISS/ISE) to support IND, NDA, IDE, IVD for 510(k) of class I, II, and PMA submissions of Class III in medical device.More...