Title: Biostatistician Location: Remote PR: $65+ - Depending on level of experience Type: Contract - Renewable Therapeutic area: Immunology & Inflammation The Biostatistician implements and executes methodological and statistical aspects of clinical studies under the supervision of Therapeutic Area lead biostatistician or project lead statistician. In some cases, principal function could be to develop/employ technical expertise in a particular statistical area or application. In this role, a typical day might include: + Under direct supervision and guidance of senior departmental staff, provide support to a clinical study + team on all relevant statistical matters. As member of study team, ensure the clinical study is conducted + in a manner that supports planned statistical analysis. + Under supervision and guidance of senior departmental staff, participate in preparation of study protocol and amendments + Perform relevant sample size calculations and write statistical methodology section of the protocol This role might be for you if have experience: + Reviewing case report form (CRF) and provide comments and feedback. + Developing statistical analysis plan (SAP). + Providing programming team with definitions and documentation for derived variables needed to produce planned Tables, Figures and Listings (TFLs). Develop data and programming specifications jointly with programmers. + Perform statistical analysis according to the SAP, validate analysis programs, review TFLs + Preparing statistical methods and results sections for the clinical study report (CSR), provide statistical insight into interpretation and discussion of study results, and work with the study team to move the CSR through review /approval process. + Supporting/participating in project related activities including preparation of BLA submissions and oversee CRO deliverables for studies contracted out To be considered for this opportunity, you must have the following: + Master Degree in Statistics or Biostatistics + 2+ years of clinical trial experience System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.