Biostatistician - Device - Remote
Category: Scientific & Clinical
Compensation Range: 150000.00 - 160000.00
Job ID: 289294
Date Posted: 02/03/2023
Start Date: 09/19/2022
Permanent and Fully remote
Salary Range $150,000 - $160,000 - Commensurate with experience
Working for a CRO, helping to build out a Biometrics department
Must have experience with Medical Device studies
STRONGLY Preferred experience with InVitro Diagnostic trials
Required Knowledge, Skills, and Experience
• Master’s Degree or PhD in Statistics, Biostatistics, Epidemiology, or other relevant degrees.
• 5 years of experience in biostatistics experience related to clinical trials and/or regulatory affairs.
• Experience within the CRO, medical device, or pharmaceutical industry is required.
o Experience and familiarity with medical devices is highly preferred.
• Knowledge of data standards for clinical research and statistical analysis including CDISC SDTM, ADaM, and ICH Statistical Principles for Clinical Trials.
• Proficiency with SAS.
o R and Python skills are a plus.
• An understanding of quality control as it relates to regulatory documentation requirements is preferred.
• Experience with adaptive trials and Bayesian analysis techniques is desired.
• Ability to read, analyze, and interpret complex documents.
• Strong research, analytical, critical-thinking, and problem-solving skills.
• Must be able to manage multiple projects and deliverables simultaneously and generate meaningful results.
• Ability to adapt to a rapidly changing environment and quickly identify new trends and changes specific to the industry.
• Strong professionalism with customer relations and managing client relationships.
• PC/Technical skills: strongly proficient in MS Office Suite, Excel, Word, PowerPoint.
• Excellent oral and written communication skills and presentation skills.
• Ability to lead a team and mentor junior team members and share knowledge
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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