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Senior Principal Biostatistician

Company: PAREXEL
Location: Hickory
Posted on: March 21, 2020

Job Description:

The Senior Principal Biostatistician leads production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents. The Principal Biostatistician provides expert level statistical support to the team, supports business development and interfaces with clients regularly. Key Accountabilities:-- Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review-- Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, as well as mentoring/training biostatisticians during their first exposure to DMCs.-- Provide strong statistical support / advice, including trial design, protocol and CRF development on specific studies-- Perform sample-size calculations, generate randomization lists and write / QC statistical methodology sections for inclusion in study protocols-- Support of Business Development, e.g. by actively contributing / leading the statistical aspects of the study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings for potential studies, programs of work and FSPs.-- Participate in and contribute to project bids, including client presentations.-- Apply and provide training in extremely advanced and sometimes novel statistical methods-- Travel to, attend and actively contribute / often lead all kind of client meetings as appropriate (eg discussing analysis concepts, presenting, discussing and interpreting study results)-- Interact with clients and regulatory authorities, including representation at key regulatory meetings on behalf of the client-- A thorough understanding of regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis-- Author or review publications. Present internally on key publications of interest-- Recognized as an expert in a particular field (i.e. DMCs, Therapeutic area, statistical method[s]), throughout the Biostatistics department worldwide-- Frequently involved in leading / contributing to key initiatives throughout GDO-- Participate in committees, task force groups as needed.QualificationsRequired Skills and Experience:---PhD or MS in Statistics or related discipline with extensive experience---10+ years of experience working in Industry - Biopharmaceutical or CRO preferred---Thorough understanding of statistical issues in clinical trials---Excellent Communication skills---Highly proficient in SAS Programming analysis---Excellent project leadership and management skills---Thorough understanding of statistical issues in clinical trials--- Excellent mentoring skills---Excellent business awareness/ business development---Ability to clearly describe advanced and/or novel statistical techniques and interpret results---Thorough understanding of regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)---Excellent negotiation skills---Client-focused approach to work.EEO DisclaimerPAREXEL 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.SDL2017

Keywords: PAREXEL, Hickory , Senior Principal Biostatistician, Other , Hickory, North Carolina

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