System One Principal Biostatistician (East Coast) in Yardley, Pennsylvania
Job Title: Principal Biostatistician
Location: 100% remote (client is in the UK so wants east coast hours)
Salary: 150-170k - 10% bonus
Global Clinical Research Organization is hiring a Principal Biostatistician to join their team. They are looking for a Biostatistician with 7-9 years of experience with 3 years of experience in vaccine trials specifically. If you want to be a part of this groundbreaking work, please apply!
Accountable for the leadership of the Biostatistics and Programming activities of a program of studies of moderate complexity and/or of high value with high impact for the organization.
Planning, monitoring, organizing and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget to the required quality. Accountabilities also include maintenance of consistency across studies.
Accountable for leading Biostatistics and Programming activities for a program of studies of high complexity and/or of high value with high impact.
Bio statistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design
Review project database structures, edit checks and data management coding conventions
Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports
Statistical analysis, Interpretation of data and reporting of results.
Writing of the statistical methods sections of integrated study reports. Reviews draft integrated study reports.
Supports responses to regulatory questions on the design of the program, and any labelling claims following submission
Participates in presentations at client and investigator meetings.
Preparation of biostatistics input to research proposals, and participates in proposal defense meetings and makes presentations at marketing meetings with prospective client.
Ongoing coaching and mentorship of team members.
M.S. degree in statistics, biostatistics, or related field with minimum of 9 years of relevant experience (at least 8 of which must be in the pharmaceutical industry); or Ph.D. in statistics, biostatistics, or related field with minimum of 7 years of relevant experience (at least 6 of which must be in the pharmaceutical industry).
7 years of experience in industry, with at least 3 years of experience working on vaccine trials (including study design, protocols submissions)
In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas.
Excellent verbal and written communication skills as well as interpersonal and project management skills
Excellent knowledge of a wide variety of principles, theories and concepts in statistics and experimental design; must be able to apply them to the development and analysis of clinical trials
Excellent knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must.
Experience leading a regulatory submission
Must be able to translate clients’ needs into statistical practice and educate clients in the use of statistics.
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.
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