Freelance Biostatistician

Oxford Global Resources is seeking a highly skilled Freelance Biostatistician to support our clients in the biotech industry.

The Freelance Biostatistician will play a crucial role in ensuring the statistical needs of clinical trials are met, adhering to regulatory standards, and driving data quality and interpretation for informed decision-making.

• Provide biostatistics leadership to assigned projects, ensuring timely delivery of key statistical deliverables.
• Develop and implement statistical analysis plans (SAPs), statistical elements in protocol development, and clinical study reports (CSRs).
• Collaborate with cross-functional teams to ensure good biostatistics practices during data management activities, including CRF development, database build, data review, and reconciliation.
• Prepare integrated summaries of safety/efficacy (ISS/ISE) and statistical-related sections of regulatory submission packages.
• Oversee internal statistical programming teams and vendors, ensuring accuracy, consistency, and quality output.
• Lead biostatistics activities in support of interim analysis, DMC activities, ad hoc analysis, and publication work.

• Master's degree 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 and regulatory guidelines (GCP, ICH).
• Familiarity with therapeutic-specific guidelines for Biostatistics and CDISC requirements for SDTM and ADaM.
• Proficiency in statistical programming with SAS and/or R.
• Ability to work with EU & US-based teams and have a basic understanding of CAR-T and clinical background.

• Full-time role with remote working options.
• 6 months contract with possible extension.