Are you an experienced Clinical Biostatistician and would like to share your experience in a dynamic Biotech company? Don't hesitate and apply now !
Job Description
The biostatistician is a functional expert in the field of clinical biostatistics, and as such supports the Clinical Study Team (CST) through design, set-up, analysis, and reporting of clinical studies. He/she performs a hands-on role, but also coordinates External Service Providers (ESP) with respect to biostatistical activities and deliverables. The Biostatistician works under the supervision/guidance of the Head of Data Science/Biostats Leader.
Responsibilities
Participate in CST and in Data Science oversight meetings as Biostatistics representative, and closely interact with Medical Leaders, Data Management, Statistical Programming, Medical Writing, Clinical Operations, and other functional representatives
- Provide statistical input in the design of phase 1-4 clinical studies, CDP, TPP including sample size calculations and simulations when needed
- Contribute to ESP selection for a clinical study
- Oversee activities with regards to randomization of the study
- Develop Statistical Analysis Plans
- Contribute to and review of regulatory documents, as per internal procedures, such as the Clinical Study Protocol, Clinical Study Report
- Provide input to the draft (e)CRF, and other relevant DM documents
- Set-up and participate in conduct of IDMC activities, including drafting of IDMC Charter
- Depending on the complexity of the study, organize one or more blinded test runs prior to database lock, and perform QC and data quality checks together with the Statistical Programmer according to the RBQR plan
- Ensure timely execution of interim analyses (if applicable)
- Organize a Blind Data Review Meeting prior to database lock (if applicable)
- Prepare and execute production of topline results (TLR) in a timely manner and contribute to any activity related to the accompanying communication plan.
- Prepare and execute production of remaining outputs (in addition to TLR) for CSR in a timely manner
- Ensure proper and timely filing of function-related documents and files in the Trial Master File or in other secured dedicated environment
- Support submission related activities, e.g., production of outputs for ISS and ISE
- Ensure proper and timely delivery of post-hoc analysis outputs for publication purposes
- Partner with Medical Affairs stakeholders in developing publications (e.g., manuscripts, oral presentations, posters, abstracts, and internal technical reports)
- Keep abreast with the regulatory landscape as well as innovative developments with regards to methodology (clinical studies and Real World Evidence)
- Gain insight in the specific disease area and the competitive landscape through focused literature search and review/summarize publicly available data
- Actively participate in Biostatistical and Data Science team meetings
- Interact with Quality & Compliance department to follow up on audit and inspection reports and assigned Corrective Action/Preventive Action plans in timely manner; participate in audits and inspections where needed
- Adhere to relevant policies and procedures and ensure timely completion of relevant training
- Lead or contribute to process improvement initiatives as required
Requirements
- Functional expert in the field of clinical study biostatistics
- Min 5 years experience as a Statistician in the pharma/biotech industry, preferably on the Sponsor side
- Master in Statistics or Closely related field
- Proficiency with computational software including SAS or R
- Demonstrated experience in design, set-up, and statistical reporting of clinical studies
- At least 3-4 years experience as a Project Statistician in oncology, with a strong preference for hematology-oncology
- Excellent ability of remote oversight of external service providers
- Proven track record as a statistical author in peer-reviewed publications and major scientific conferences.
- Good knowledge of the applicable regulatory guidelines
- Excellent level of English oral and written
- Existing right to work in Europe required
Benefits
- Fulltime position as a Employee or Freelancer
- Remote / Office based : 1 day/week at the office in Mechelen or Leiden
- A balanced salary package based on your capabilities and experience, including extra legal benefits
Vacancy number: 26134
