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 Principal Biostatistician to join our Biostatistics 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:
- 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, perform quality control of analysis data and TLGs
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field
- 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
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 considers immigration sponsorship to be an important part of recruiting, hiring, and retaining an innovative workforce. The company will sponsor work visa and green card applications for qualified employees in compliance with our Visa Sponsorship Policy. Sponsorship is not a guarantee of employment.
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.