Senior Biostatistician: Clinical Trials & Submissions Lead

Cytel; Greater London; Presencial; GBP 75.000 - 110.000; Jornada completa

Descripción de la vacante

Cytel is seeking a Senior Biostatistician to support or lead clinical studies from design through submission. You will perform ad-hoc and regulatory-relevant analyses, collaborate with clients and CROs, and contribute to SAPs, CSRs and data standards.

You will have a strong statistical background, experience with CDISC/ADaM, and excellent communication to explain methodology. This role is embedded with a pharmaceutical client and requires proactive leadership.

Formación

• Master's degree in statistics or related discipline; PhD preferred.
• 5+ years of clinical trial experience.
• Experience with SAS and R; QA outputs.
• CDISC standards for regulatory submissions; ADaM experience.
• Experience in protocol development and SAP.

Responsabilidades

• Providing statistical support to clinical studies
• Participating in the development of study protocols, including design discussions and sample size calculations
• Reviewing CRFs and data review guidelines; developing SAPs, including analysis datasets and TLG specifications
• Performing statistical analyses and interpreting results
• Preparing clinical study reports, including integrated summaries for submissions
• Utilizing strong communication skills to present and explain methodology and consequences of decisions
• Understand and follow FDA regulations which affect reporting of clinical trial data; good clinical practice and e-submissions guidelines
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners) to meet timelines
• Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

Conocimientos

Clinical trial support

Communication

Regulatory understanding

Statistical programming

Educación

Master's degree in statistics

PhD strongly desired

Herramientas

SAS

R

CDISC

ADaM

Descripción del empleo

Cytel is seeking a Senior Biostatistician to support or lead clinical studies from design through submission. You will perform ad-hoc and regulatory-relevant analyses, collaborate with clients and CROs, and contribute to SAPs, CSRs and data standards.

You will have a strong statistical background, experience with CDISC/ADaM, and excellent communication to explain methodology. This role is embedded with a pharmaceutical client and requires proactive leadership.