About the vacancy
Data & Analytics
About Your Next Job
You will provide oversight of biostatistical activities across clinical trials and real-world evidence studies, including the management of CROs supporting MA and BLA submissions. You contribute to statistical analysis planning, and contibute to the development of high-quality regulatory deliverables including ISS, ISE, SCS and SCE.
About Your Next Colleagues
We are a team of 30 at JCR Europe, all seasoned professionals, working hard to build up the organisation and bring our product to patients in Europe.
About Your Tasks and Responsibilities
Provide oversight and direction to CROs and external vendors deliverig statistical services for clinical trials and RWE data, ensuring quality, compliance and timely delivery witin budget.
You provide input into the development of integrated safety and efficacy documents (ISS, ISE, SCS and SCE) in collaboration with regulatory and medical writing teams.
About Your Skills and Experience
You do have experience on the sponsorside, preferably also on the CRO side.
You need to have >10 years of relevant experience.
Where Molecules Meet Opportunities
This is an assignment for 12 months. You can work Remote (in Europe) or at our office in Leiden.
Only apply if...
Please indicate your availability (as of when and how many hours a week) and your hourly/daily rate
Contact person
Alice Stuurman
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JCR Pharmaceuticals Co., Ltd. is a fully integrated specialty Biopharmaceutical company focusing on the treatment of rare diseases including growth hormone deficiency, anemia, graft-versus-host disease, Fabry Disease and Mucopolysaccharidosis Type II. Founded in 1975 and headquartered in Ashiya, Hyogo prefecture, JCR has around 900 employees, with biomanufacturing sites and research centers in Kobe (Japan), and overseas subsidiaries in San Diego (USA), Leiden (Netherlands), and Sao Paulo (Brazil).