Principal Biostatistician

December 7

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KCR

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Clinical Monitoring • Functional Service Provider • Site Set up and Contracting • Late Phase • Medical & Regulatory Affairs

501 - 1000 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• Responsible for statistical analysis of all relevant studies • Develop Statistical Analysis Plan for conducted studies • Create TLF shells and write specifications for Statistical Programmer • Provide input for protocol development and develop statistical section of the protocol • Review eCRF prior to finalization to ensure design criteria are met and all relevant information to support planned analyses is captured • Works as Statistical Team Lead to monitor and review the progress of the statistical deliverables on the assigned studies • Responsible for quality assurance of reported results and their statistical interpretation • Communicate with clients regarding study protocol and/or statistical analysis issues • Develop Biostatistics knowledge by participating in external trainings and self-training • Maintain awareness of all statistical guidelines (ICH, EMA, FDA)

Requirements

• Master’s degree in statistics or equivalent • At least 5 years of experience in the pharmaceutical, biotechnological industry or CRO • Strong working knowledge of SAS. Basics in R and Python preferred • Excellent written and oral English communication skills, including grammatical/technical writing skills • Ability to establish and maintain effective working relationships with co-workers, managers and clients • Ability to effectively manage multiple tasks and projects • Knowledge of CDISC data standards and models

Benefits

• A valuable healthcare and wellbeing benefits package (private health plans, life insurance, travel insurance, disability insurance, private retirement fund) plus additional discount programs • Ability to join fast-growing international CRO company and develop knowledge of clinical trials industry. • Empowering workspace, with a flat hierarchy, offering opportunities to share ideas and influence company services development worldwide. • Possibility of getting involved in multinational studies. • Onboarding process to enable you fast takeover of duties and Buddy Mentor who will introduce you to the organization. • Open culture based on our values: learning, customer focus, accountability, commitment, tenacity, and determination to succeed.