About the vacancy
Bioinformatics
About Your Next Job
You support statistical programming activities across clinical trials and real-world evidence studies, with a strong emphasis on CDISC standards and regulatory submissions (MAA, BLA).
About Your Next Colleagues
We are a great team of experienced people, working remote across Europe. We love the vibe of a scale-up: hands-on, can-do mentality, pragmatic.
About Your Tasks and Responsibilities
You will lead and coordinate statiscal programming activities for regulatory submission (e.g. MAA, BLA). You will perform QA and validation of statistical programmin deliverables. You will be part of the Biostatistics team.
About Your Skills and Experience
You do have experience with regulatory submissions and associated components, preferably both on the CRO and sponsor site. You have a deep understanding of regulatory submission requirements, including ISS/ISR, SCS/SCE, and eCTD structure
You do have strong knowledge of CDISC standards (CSDTM, ADaM).
You are fluent in English.
About Your Benefits
Working in a great team of professionals with a drive to bring a product to patients.
Where Molecules Meet Opportunities
This is an assignment for 12 months. You will be working remote or in our office in Leiden (the Netherlands).
Only apply if...
Please indicate your availability (as of when and how many hours a week) and your hourly/daily rate
You are eligible to work in EU
We only accept applicants who are eligible to work in the EU
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).