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- (Boston)Hengrui Pharma • Boston, MA, United States
- (Boston)

- (Boston)

Hengrui Pharma • Boston, MA, United States
13 days ago
Job type
  • Full-time
Job description

a) /

b)

c) SAPCSRTFL

d) SAS

e) CSR TFL

f) SAPCSR

g) CRO

h)

3 CRO /

  • / SASREAST
  • GCPICH

Responsibilities

  • 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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