Biostatistician

Provides statistical input in developing the following clinical operational documents:

· Protocols including design, sample size and statistical methods to be used

· Statistical Analysis Plans, including ISE and ISS

· Template Tables, Listings and Figures

Perform statistical operations:

· Randomization code generation

· Statistical Analysis Program Development for reporting of study results for SAP and CSR and other regulatory submissions

· Exploratory or ad-hoc analyses to the requests

Provide statistical support to cross-functional teams:

· Working with Data Manager and Programmer to verify database updates

· Coordinating of data and table review activities

Master or PhD Level in Statistics or Biostatistics with at least 5 year Pharmaceutical company/CRO experience

Knowledge of clinical trial methodologies, drug development, and FDA GCP/ICH regulatory guidelines

Proficiency in SAS programming and macros required

Interpersonal skills to work in a dynamic team environment

Good verbal and written communication skills

Perform peer-review of SAS programs in accordance with quality assurance/quality control (QA/QC) policies

Possess the ability of working on multiple projects simultaneously and also have the flexibility of working both collaboratively and independently in a multidisciplinary project environment