Biostatistics Management Trainee

1.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, publications (abstracts, posters, manuscripts), etc

g) Works collaboratively with internal and external (e.g. CRO) team members to coordinate the planning and execution of day-to-day biostatistics deliverables

h) Provides statistical interpretation and explanation of data analysis results to cross-functional teams

2. Ensures study design and statistical methods for data collection, processing and analysis are scientifically sound and can clearly and robustly address the objectives of the clinical trial and program

3. Collaborates and oversees statistical works outsourced to CRO/external vendor to ensure high quality and on-time delivery

4. Good knowledge of disease, compound and regulatory guidance within the focused therapeutic area

5. Provides good-faith challenge to the cross-functional trial team with respect to study design, data analysis and interpretation

Education:

Ph.D. degree in Biostatistics, Statistics or an equivalent field

Experience:

• Experience in designing clinical trials and conducting data analysis;
• Experience of interaction with regulatory authority is preferred for MS level candidate;
• Knowledge of / experience with SAS, R, EAST, or other business or research analytic software;
• Knowledge of data architecture

Language Requirement:

Fluent in both written and verbal English