Manager, Biostatistics
Cranbury, NJ
Experience: 0
Category: Scientific & Clinical
Brand: Joule
Compensation Range: 140000.00 - 155000.00
Job ID: 288929
Date Posted: 03/07/2023
Shortcut: http://jobs.systemoneservices.com/Ed3cod
Manager, Biostatistics
CRANBURY, NJ - can consider Fully Remote - US East Coast only
BIOSTATISTICS
FULL TIME
The Manager, Biostatistics, is a member of the biostatistics and programming team and plays a lead role in performing all statistics tasks required for clinical trial analysis and reporting. This individual works closely with clinical development, statistical programming, and data management colleagues on various clinical projects and may function as a lead statistician on multiple projects.
Responsibilities:
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- Manages or leads biostatistics assignments on multiple projects.
- Remains informed of new developments in biostatistics and programming that are relevant to the industry.
- Establishes and implements biostatistics and programming standards and complies with regulatory requirements among project team members and across studies.
- Programming in SAS and/or R for data analysis and reporting.
- Assists with statistical quality assurance review.
- Reviews deliverables before transfer to either internal or external clients.
- Performs statistical services to achieve timely, quality, and cost-effective deliverables, including SAP, TLF shells, and dataset spec development.
- Participates in the development of and ensures compliance with Standard Operating Procedures (SOPs), policies, and guidelines related to statistics and programming.
- Hands-on programming for TLF deliverables required statistical inference.
Requirements:
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- MS degree in statistics or equivalent training required. Ph.D. preferred
- A minimum of 6 years of industry or CRO experience required
- Must have experience with importing external control data
- Experience leading statistical projects in the pharmaceutical industry, demonstrated by the ability to independently function as the point of contact for statistics over all phases of clinical trials
- Proficient in industry standards, medical terminology, and clinical trial methodologies
- Possesses project management skills within the biostatistics function
- Regulatory (FDA and EMA) submission experience is not required but is considered valuable for an optimal candidate
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, 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.
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