For one of our clients, a biotech with headquarters located in Germany, we are looking for a Freelance Biostatistician.
Job Description
The Biostatistician will play a pivotal role in supporting the statistical needs for clinical trials, ensuring adherence to regulatory standards, and driving data quality and interpretation for informed decision-making.
Responsibilities
- Provide Biostatistics leadership to assigned projects
- Ensure delivery of key statistical deliverables to include statistical elements in protocol development and clinical study report (CSR), statistical analysis plans (SAPs) and TLFs, data analysis, and statistical result interpretation.
- Ensure good Biostatistics collaboration during the execution of key data management activities to include CRF development, database build, data review and reconciliation, and database lock activities.
- Ensures inputs for preparation of integrated summaries of safety/efficacy (ISS/ISE) and statistical related sections of regulatory submission packages (e.g., eCTD M2.5, M2.7 and M5 for NDAs/BLAs/MAAs), including INDs and EMA variation submissions.
- Provide statistical inputs and direction in the oversight of internal statistical programming team, including the production and QC the statistical deliverables, ensuring accuracy, consistency, and quality output.
- Provide statistical inputs and direction in the oversight of vendors that conduct statistical work, including the production and QC the statistical deliverables, ensuring accuracy, consistency, and quality output.
- Ensure good Biostatistics collaboration during dry-runs to QC key efficacy and safety data and resolve identified data and programming issues.
- Lead Biostatistics activities in support of interim analysis, DMC activities, ad hoc analysis, and publication work.
- Spearhead the development and revision of statistics, SOPs and process improvement.
Requirements
- MS in Statistics/Biostatistics or a PhD in Statistics/Biostatistics or a related field with at least 3 years of clinical trials experience in Biopharma/CRO.
- Strong knowledge of the drug/biologic's development process
- Thorough understanding of regulatory guidelines (GCP, ICH)
- Familiarity with therapeutic-specific guidelines for Biostatistics
- Availability to work with EU & US-based teams (time zone difference)
- Basic understanding of CAR-T and clinical background
- Proficiency in statistical programming with SAS and/or R
- Familiarity with CDISC requirements for SDTM and ADaM
- Ability to oversee statistical programming, ensuring accuracy, consistency, and quality
- Strong statistical input for interim analysis, DMC activities, and publication support
Contract Information
- Full-time role
- Remote working
- 6 months contract with possible extension
