Senior Biostatistician (Contractor Romania)

Description

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

What you’ll be doing:  

• Independently utilize your respected expertise to provide statistical consulting
• Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
• Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
• Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
• Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
• Independently prepare analysis data specifications
• Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
• Perform quality control of analysis data and TLGs
• Review and provide input in interpreting analysis result to clinical study report

What we are searching for:     

• Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
• Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
• Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
• Detail oriented, well organized with the ability to work on several projects simultaneously
• Excellent team player, collaborative and maintains a positive, results-orientated work environment
• Accountable, dependable and demonstrates strong commitment to the role
• Is customer service focused in approach to work, both internally and externally

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
• Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.