BIOSTATISTICIAN

Role and Responsibilities:
Provide statistical expertise for design analysis and reporting of clinical or
scientific research studies (including Phase IV) or programs. Experience with SAS
R Python and healthcare claims data.
Protocols: Provide study design calculate sample size develop randomization
specifications and write statistical analysis plans to address study objectives.
Ensure alignment of the protocol with project and functional standards. Conduct
a quality review of protocol and provide appropriate feedback.
Database Activities: Assist in identifying scientifically appropriate data collection
instruments. Ensure data collection is free of bias. Provide programming
specifications for derived variables and analysis datasets. Assist with the
development and implementation of projectspecific data standards. Identify and
report data issues or violations of study assumptions. Guide programmers and
data managers in preparing for database lock. Ensure the accuracy of data
released for statistical analysis.
Statistical Analyses: Explain statistical concepts to nonstatisticians. Develop
analysis plans ensuring statistical methods are appropriate with the study design
with detail for programming. Ensures internal consistency of analysis plans.
Perform statistical analyses per the SAP. Independently anticipate need and
implement complex statistical methodology. Evaluate available statistical
methodology and software and the need for novel statistical methodology.
Reports and Publications: With project team develop strategy for data
presentation and inference. With supervision write statistical methods and other
sections of protocols publications etc. ensuring document templates followed.

Job Description

JD template Version: 02; Effective Date: 16Sep19 Page 2 of 2
Identify and implement corrections to flaws in statistical interpretation.
Collaborate in publication of scientific research. Ensure analyses conducted as
planned with accuracy and internal consistency of writing including tables listings
and figures.
Requirements for consideration:
PhD or MS (with at least 5 years of relevant experience) or in Statistics
Biostatistics
Deep experience with RWE data