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Senior Biostatistician

Company

Hengrui Pharma

Location

boston, United-States

Type

Full-time

Main Responsibilities:

Functions as the lead trial statistician for clinical trials:

a) Contributes to the study design of a clinical trial, including but not limited to specifications of study objectives, endpoints, hypothesis testing strategy, sample size/power calculations

b) Author of the statistical sections of the trial protocol

c) Author of the Statistical Analysis Plan (SAP), as well as the templates of tables, figures and listings (TFLs) to be presented in the Clinical Study Report (CSR), regulatory documents, publications

d) Supports the development of SAS codes to implement the pre-planned and ad hoc data analyses, as well as to prepare data displays

e) Supports the validation of the generated study datasets and CSR TFLs, outputs for regulatory documents and publications

f) Participates in the writing, review and finalization of regulatory documents including but not limited to protocol, SAP, CSR, publicat...

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