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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

About Precept Life Sciences:

Precept Life Sciences is a premier professional workforce solutions firm headquartered in Sterling, Virginia. Established in 1999, Precept possesses a proven track record of providing key talent for the dynamic Life Science industry within North America. With over 70 years of combined recruiting experience, our team consists of degreed scientists who quickly comprehend complex technical requirements, enabling us to accurately identify the right talent for you. Precept specializes in supporting the Pharmaceutical, Biotech, Medical Device, CMO/CRO industries within the following skill sets. From single placements to comprehensive workforce solutions projects, Precept is committed to offering the right-sized solution for our customers. Simply put, we strive to be your most valued resourcing partner operating within our core values; Integrity, Excellence, Expertise, Results.

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