Senior Principal Biostatistician

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job Location: 275 Grove Street, Newton, MA 02466 and may telecommute from anywhere within U.S.

Job Title: Senior Principal Biostatistician

Job Duties: The Senior Principal Biostatistician at Parexel International LLC in Newton, MA will work independently on complex clinical trial programs and projects with major regulatory impacts. Provide day-to-day technical and operational leadership to project teams supporting these programs and projects. Act as subject matter expert in biostatistics. Support business development by providing input into study proposals, including budget costs and preparing and attending bid pursuit meetings. Conduct clinical studies to generate data and insights to innovate, plan, and support improved healthcare outcomes and processes. Contribute to protocol development by choosing study design and statistical methodologies, and writing section on protocol statistics. Lead production and quality control of sample size calculations, randomization plans, statistical reports, statistical methodology sections of integrated clinical study reports, and other process supporting documents. Author and prepare statistical analysis plans (SAP) to ensure the best statistical methods are developed and utilized. Write specifications for files, consistency checks, tables, and calculations used to collect and analyze data from a variety of sources. Build and interpret advanced statistical models to analyze data collected from repeated measures of experimental designs with/without missing data. Provide biostatistical input into Data Monitoring Committees (DMC) activities, including development of DMC Charter and DMC SAP. Proficient with statistical computer applications like SAS and R. Interface with non-technical users to assist with data interpretation and understanding results. Telecommuting permitted from anywhere within the US.

Minimum Requirements: Requires a Master’s degree in Biostatistics, Statistics, or a related field, plus 4 years of experience in statistics, including: (1) programming with SAS (BASE, STAT, GRAPH, SQL, CONNECT, and ACCESS) and R; (2) preparing statistical analysis plans and statistical reports; (3) data cleaning and validation; (4) performing statistical analysis, including generalized linear model and surviving data analysis; (5) translating statistical issues for non-statisticians; (6) building and interpreting statistical models using clinical data; (7) statistical methodology and data analysis in an FDA-regulated environment (21 CFR Part 11); and (8) Responsive Evaluation Criteria in Solid Tumours (RECIST) 1.1 and CDISC standards.

To apply, please send resume to openings@parexel.com and cite requisition number 00844, or apply at jobs.parexel.com.

EEO Disclaimer
Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.