Manager Biostatistics – Remote

Manager Biostatistics – Remote

Premier Research Group Limited

Job Description

At Premier Research, The Company helps 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 healthier future. 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.

Their dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities to have the tools they need to succeed.

The Company is looking for a Manager of Biostatistics 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.

Responsibilities

• 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 develops statistical analysis plans
• Acts as Lead Biostatistician to interact with the study team and the Sponsor
• 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
• Acts as Project Manager for one Biostatistics stand-alone project and completes consultancy work as needed
• Supervises, mentors, and motivates reporting associates in tasks and activities to develop the team structure

Requirement

• Previous experience in clinical trials design and analysis using SAS
• Previous experience as supervisor/manager
• Prior experience using computerized information systems is preferred.
• Ability to read, write, and speak fluent English; fluent in host country language.
• 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.
• Identifies, monitors, documents, and tracks out-of-scope activities.
• Demonstrated experience in interactions with regulatory agencies (e.g., FDA, EMA, EU member states, etc.)
• Fluent verbal, written, and interpersonal English and the local language(s) required for clinical trial submissions.
• Excellent team player, collaborative, and able to build an effective team.
• Ability to multitask and work effectively in a fast-paced environment with changing priorities.
• Strong verbal and written communication and negotiation skills.
• Excellent organizational and time-management skills, able to prioritize work to meet deadlines.
• Accountable, dependable, and strong commitment

Why choose Premier Research? ·Premier Research is more than a company – it’s a community of people who genuinely care about one another, our clients, and our mission of furthering research to improve patients’ lives in critical need.·Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, and 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 to have the tools they need to succeed.At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly.

We strive to create a community of belongingness where our differences are welcomed and celebrated through a commitment to diversity, equity, inclusion, and empowerment. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.

Average Salary:£81,000