The Principal Biostatistician takes a statistical leadership role in the methodological development of clinical projects and assists the Head of Biostatistics in managing the biostatistics team as appropriate. Independently and collaboratively works across global multi-disciplinary clinical study teams on both in-house and outsourced clinical trials. She/He will provide expert statistical support to the biometrics group, study and project teams and any other function that requires 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 to meet project deliverables and timelines.
• Lead the discussions with functions outside of clinical development about publications, post market studies, RWD/RWE 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, assessment of protocol deviations, estimands and analysis sets.
• 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 support frontline on FDA advisory committees and all regulatory meetings globally.
• 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 when required
• Able to travel globally
• Other duties as assigned.

Minimum Job Requirements

Qualifications

• MS or PhD in Biostatistics or related field.
• At least 4+ years of relevant experience with PhD or 6+ years with MS Biostatistics experience in pharmaceutical/biotech industry, or a related academic affiliated research institution conducting clinical trials.

Competencies

• 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 in SAS® and R languages as a minimum.
• Overseeing the progress of biostatistics activities with minimum support.
• Strong written, oral communication and interpersonal skills.

Other Requirements

• Core member experience with FDA/EMA/CHMP 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
• Strong leader able to take tactical command on matters of GCP and GSP
• Good CRO oversight and team management skills
• Experience of late-stage biomarker analysis preferred
• Leading global teams when required

• This position has significant managerial and decision-making authority.
• Ability and willingness to travel approximately 20% of the year both domestically and internationally
• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month

To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.

Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.