Manager, Biostatistics - India

Description

Premier Research is looking for a Manager Biostatistics to join our Biostatistics team. You will help bio tech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• 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.

Together, we are Built for Biotech. Join us and build your future here.

What you’ll be doing: 

• Supervising, mentoring, and motivating reporting associates in tasks and activities in order to develop and maintain the team structure
• 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 
• Contributing to the tracking of project revenue and backlog
• Contributing to efforts in Biostatistics project costing estimates and bid defences
• Leading efforts in the development, maintenance and adherence to departmental SOPs, guidelines, and processes

What we are searching for:  

• Advanced degree (MSc or PhD, or equivalent) in statistics or closely related field along with previous of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
• Experience as a manager is desirable, but we will also consider applications from experienced statisticians looking to move into a management role
• 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

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.