System One Principal Biostatistician in Florham Park, New Jersey
Reports to (Position):
Corporate NJ (hybrid role)
Purpose and Scope of Position
Takes a statistical leadership role in the methodological development of clinical projects and managing the biostatistics team. Collaboratively works across multi-disciplinary clinical study teams on both in-house and outsourced clinical trials. Provide expert support for statistical methodology to the biostatistics group and project team and other functions that require statistical input.
Perform duties of a Project/Study Statistician to support clinical projects/trials (both early stage and phase II and III).
Provide expertise towards the planning of study designs, data collection, data monitoring and results interpretation
Prepare statistical methodology sections for protocols and Statistical Analysis Plans (SAPs) with minimum support from Statistics Management.
Work collaboratively and globally with statistical programmers, biostatisticians, data managers, clinical teams, regulatory and project management staff and medical affairs to meet project deliverables and timelines.
Leader in the discussions with functions outside of clinical development about publications, post market studies and HTA, but not limited to those.
Manage CRO oversight with minimum supervision from Statistics Management to ensure the quality and timeliness of deliverables from the CRO.
Lead the creation of QTLs.
Propose and perform other ad-hoc statistical activities as needed for both internal and external requests including publications and information requests from regulatory agencies, and as needed analyses to support an FDA advisory committee or other regulatory meetings.
Author (key sections) and review final study report and prepare statistical sections with minimum support from Statistics Management.
Attend global meetings via teleconference during early morning or late evening hours.
Some (minimal) travel is possible
Supervisory | Decision-Making Authority
Mentoring junior statisticians
Involved in recruiting, overseeing, and mentoring Biostatistics Department Summer Interns
Minimum Job Requirements
MS or PhD in Biostatistics or related field.
At least 2-3+ years with PhD or 3-5+ years with MS Biostatistics experience in pharmaceutical/biotech industry, or a related academic affiliated research institution conducting clinical trials.
Good statistical knowledge and experience in all phases of drug development including trial design.
Good knowledge of health authority and ICH guidelines.
Good programming experience to produce the TLFs.
Overseeing the progress of biostatistics activities with minimum support from senior persons.
Minu Job Requirements
Preferred Skills and Experience
Strong written and oral communication and interpersonal skills.
Core member experience with FDA submission and CTD preparation.
Demonstrate a sound thought process and a willingness to challenge the status quo.
Developing solution to a variety of problems with minimum guidance from senior persons.
High-level CDISC knowledge
Good leadership skill
Good CRO oversight and team management skill
Harmonizing global team work well
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.