Biostatistician - Remote

Looking to apply your statistical expertise to real clinical research impact? We’re partnering with a leading pharmaceutical organization seeking a Biostatistician to support clinical studies across General Medicine programs. This is a great opportunity for statisticians with pharma clinical trial experience who want to contribute to protocol development, statistical analysis planning, and regulatory deliverables while working fully remote.

If you enjoy collaborating with cross-functional study teams, developing SAPs, TFL specifications, and statistical analyses, and helping drive clinical programs forward, this role offers the chance to work on meaningful studies while expanding your experience in a fast-moving research environment.

We are seeking candidates with pharmaceutical industry experience and at least 2 years of biostatistics experience in clinical trials.


Job Responsibilities
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.

• Review case report form (CRF) and provide comments and feedback.
• Develop statistical analysis plan (SAP).
• Provide 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, prepare
• 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.
• Support/participate in project related activities including preparation of BLA submissions and oversee
• CRO deliverables for studies contracted out

• Master Degree in related field required
• 2+ years of relevant experience

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions 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 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.

#LI-ES1
#M-
#LI-
#DI-

Ref: #568-Clinical