Functions as the lead trial statistician for clinical trials :
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
Author of the statistical sections of the trial protocol
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
Supports the development of SAS codes to implement the pre-planned and ad hoc data analyses, as well as to prepare data displays
Supports the validation of the generated study datasets and CSR TFLs, outputs for regulatory documents and publications
Participates in the writing, review and finalization of regulatory documents including but not limited to protocol, SAP, CSR, publications (abstracts, posters, manuscripts), etc.
Works collaboratively with internal and external (e.g. CRO) team members to coordinate the planning and execution of day-to-day biostatistics deliverables
Provides statistical interpretation and explanation of data analysis results to cross-functional teams
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
Collaborates and oversees statistical works outsourced to CRO / external vendor to ensure high quality and on-time delivery
Good knowledge of disease, compound and regulatory guidance within the focused therapeutic area
Provides good-faith challenge to the cross-functional trial team with respect to study design, data analysis and interpretation
Qualifications
Education : Master degree in Biostatistics, Statistics or an equivalent field with about 3 years relevant work experience, or a 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
Other Skills : Good interpersonal and communication skills
Requirements
Ability to learn and apply appropriate statistical methods to solve complex problems while also focus on quality of work
Knowledge of disease, compound and regulatory guidance including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Ability to work collaboratively and efficiently in a cross-functional team
Good communication skills and ability to build sound relationship with cross-functional team members
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Boston • Boston, MA, US
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