JOB TITLE – Biostatistician

GENERAL SUMMARY OF DUTIES – Responsible for ensuring that appropriate statistical techniques are used which guarantee the scientific validity and overall quality of clinical trial results.  Perform statistical analysis, contribute statistical input when requested, and represent the Biostatistics function of SCRI to external partners.

DUTIES INCLUDE BUT ARE NOT LIMITED TO:

* Perform protocol development/sample size calculation & protocol/CRF review

* Work cooperatively with SCRI scientists and authoring physicians.

* Work cooperatively with vendors and other external partners

* Represent SCRI to external partners in a professional manner

* Coordinate the development of  randomization schema

* Coordinate & develop statistical analysis plans

* Coordinate & perform data review & statistical analyses

* Coordinate and produce tables, listings & figures

* Write statistical sections for integrated reports and statistical reports

* Advise DM with respect to database design, validation checks & key data

* Set and maintain professional statistical standards

* Provide an oversight of SAS programming

* Maintain & archive program documentation - both electronic & paper - in an appropriate manner

* Understand and apply regulatory statistical guidelines/developments

* Keeps management abreast of issues and progress on all assigned projects

* Contributes to internal process development and improvement

* Performing related work as required

* Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement”

* All other duties as assigned

KNOWLEDGE, SKILLS, & ABILITIES – This position requires the following minimal requirements:

* Ability to work with within deadlines

* Excellent knowledge in statistical theory including experimental design, categorical data analysis, analysis of variance (covariance), survival analysis, non-parametric methods

* Must be familiar with ICH guidelines and other regulatory requirements related to biostatistical activities

* Ability to manage multiple protocols and participate on multiple project teams simultaneously

* Strong attention to detail

* Excellent communication skills, oral, written and presentation

* Excellent organizational skills

* Excellent problem solving skills

* Excellent teamwork skills placing emphasis on supporting the goals of the group

EDUCATION

Minimum of a B.S. in statistics or related field.

EXPERIENCE

Three years experience in regulated clinical research required

Experience in SAS programming is required