Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.  

We’re looking for a Senior Manager Biostatistics to join ourBiostatistics team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

What you’ll be doing: 

• Independently develops SAS programs to generate listings, tables and figures as outlined by a statistical analysis plan and to generate randomization codes
• Performs QC of TLFs, CDISC and other analysis data sets
• Prepares specifications for CDISC and other analysis data sets; independently develop statistical analysis plans
• Acts as Lead Biostatistician to interact with the study team and the Sponsor
• Provide strategic approaches to support direct reports with complex project challenges
• Guide and mentor direct reports to achieve and overcome personal development goals and obstacles while providing positive and constructive feedback
  
• Supports Business Development by preparing for and attending bid defense meetings, preparing capabilities presentations, and assisting with budget and proposal development
• Acts as an independent Biostatistician on DSMBs and DMCs

What we are searching for:  

• Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field
• Previous experience in clinical trials design and analysis using SAS
• Previous experience as supervisor/manager
• Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
• Works with internal and external customers/vendors to meet project specific goals.
• Demonstrated experience in interactions with regulatory agencies (e.g., FDA, EMA, EU member states, etc.)

Why choose Premier Research?  

• 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 cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the 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.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

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