Biostatistics Coordinator (Remote)

The Biostatistics Coordinator reports to the Head of Biostatistics and is responsible to coordinate and supervise statistical activities across a diversified portfolio of clinical projects. The Biostatistics Coordinator also acts as a senior statistician for specific projects, ensuring statistical activities are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs. The Biostatistics Coordinator promotes the use of rigorous statistical methodologies, contributes to acquiring new associates and acts as a mentor for junior staff. 

Specific Tasks

Collaborate with the Head of Biostatistics in coordinating and supervising the activities of the Statistical team; - Ensure processes are correctly applied within the Statistical team; - Liaise with the study team, Sponsors and external stakeholders regarding statistical activities, study design and results of statistical analyses; - Collaborate with the Head of Biostatistics in defining the timeframes and costs of each project and preparing the biddings and invoices for the Sponsor; - Collaborate in establishing and maintaining document/programming standards; - Can act as a senior biostatistician in case of specific projects; - Collaborate with Head of Biostatistics to establish and to maintain SOPs related to the Biostatistics Unit; - Monitor updates in regulations and statistical methodology in clinical research applicable to OPIS activities and support related implementations; - Present and share knowledge at team meetings; - Organize/perform trainings for project team and acts as a mentor for junior staff; - Contribute to hiring and on-boarding of new associates.

Requirements

- Master Degree in Statistics (or equivalent degree) with a specialization in medical or epidemiological statistics;

- At least 3 years of experience in CRO, biotech, pharma, research institutes or similar;

- Proven knowledge and expertise in statistics and its applications to clinical research;

- Solid knowledge and experience in drug development process and GCP guidelines;

- Solid knowledge of SAS and other statistical software packages;

- Experience in developing CDISC standard specifications and datasets (SDTM, ADaM);

- Knowledge of computer systems related to clinical trials (EDC, IVRS, IWRDS, EPRO, CTMS, etc.);

- Project Management and problem-solving skills;