Senior / Principal Statistician

Senior Statistician

Job Purpose

The Senior Statistician will provide statistical expertise across clinical development programs. This includes the creation and review of statistical analysis plans, SAS® and R programming for descriptive and inferential analyses, and statistical support for clinical protocols and clinical study reports across sponsored and managed clinical trials. The role will also contribute scientific input on statistical methodologies used in the design of clinical studies.

Key Responsibilities

• Act as lead/statistical representative on assigned clinical studies within cross-functional project teams.
• Support oversight of biometrics and external vendors, including timelines, deliverables, and quality review of outputs.
• Provide statistical input into clinical trial design and protocol development.
• Author and review Statistical Analysis Plans (SAPs).
• Review database setup documentation, including Data Management Plans, Case Report Forms (CRFs), database specifications, and edit check specifications.
• Support clinical data review activities, including Tables, Figures and Listings (TFLs), CDISC datasets (SDTM and ADaM), and regulatory submission packages such as define.xml, Pinnacle21 outputs, and Data Reviewer Guides.
• Contribute to regulatory submission activities, including NDA/MAA documentation and review of Clinical Study Reports (CSRs).
• Collaborate closely with Medical, Clinical Operations, Imaging, Regulatory Affairs, and other cross-functional teams.
• Undertake additional responsibilities as required by business needs.

Education

• BSc (Hons) in Mathematics, Statistics, or another scientific discipline.
• Postgraduate qualification (MSc or PhD) in Statistics or Statistical Science preferred.

Experience, Knowledge & Technical Skills

• Demonstrated experience applying statistical methods within clinical trials.
• Experience planning and supporting clinical data analysis activities, including electronic data capture systems.
• Experience working with external vendors supporting data management, programming, and statistical activities.
• Understanding of regulatory submission processes and standards, including NDA/MAA deliverables.
• Strong knowledge of CDISC standards, including SDTM and ADaM.
• Good understanding of the drug development lifecycle and regulatory filing processes.
• Strong SAS programming knowledge and understanding of programming best practices within clinical development.
• Familiarity with Good Clinical Practice (GCP) regulations and requirements.
• Oncology and/or diagnostic imaging experience is advantageous.

Key Competencies

• Ability to work effectively in a fast-paced environment while managing multiple priorities and deadlines.
• Strong project planning and effort estimation skills for programming and statistical activities.
• Experience working within cross-functional and matrix organisations.
• Excellent written and verbal communication skills.
• Adaptable mindset with a collaborative and proactive approach to change.