Principal Biostatistician

The Biostatistician is responsible for the design, analysis, and/or interpretation of clinical studies as a lead (or contributing team members) for clinical studies.

In this role, the biostatistician will be part of a collaborative team that works with the sponsor, PM, clinical team, data mangers, medical writers, statistical programmers, and potentially many other team members to support the statistical needs of the assigned clinical study(ies).

The biostatistician is responsible for (or participates in) the creation, review, maintenance, and oversight of all contracted statistical output and activities. These responsibilities may include, but are not limited to, relevant sections of the clinical protocol, the statistical analysis plan, data/safety review meetings, content development specifications, and review (or input into) relevant sections of summary reports.

• Serve as a lead statistician for multiple studies, clinical programs, integrations, submissions, adaptive designs, and other complex studies.
• Provide review and oversight to statistical output created by other members of the biostatistics department.
• Provide consultative support to sponsors and/or internal teams regarding topics of study design, exploratory analyses, statistical methods, and other relevant topics.
• Represent sponsors in regulatory meetings.
• Present relevant statistical output and findings to Safety Review Committees (and other similar bodies).
• Represent biostatistics in qualification audits, study audits, and other pre-trial assessment activities.
• Represent the function in bid defences and other sales related activities such as review of RFP content; including input to the budget, suggestions related to study design, and other contributions to the opportunity strategy.
• Lead initiatives and process improvement activities on behalf of management.
• Supports the head of Biostatistics (and as needed, Head of Biometrics) on topics related to statistical issues, process improvement, industry trends, and other relevant topics.

Requirements

Education

Bachelor's Degree, preferably in Computer Science, Mathematics/Statistics, or a quantitative natural science.

• Thorough knowledge of SAS programming and statistical programming topics relevant to clinical trials including statistical analysis-based procedures and/or indication specific methods; may have expertise in one or more topics.
• Advanced CDISC knowledge

Experience

Minimum of 8 years’ of related experience, or equivalent combination of skills and education

Special Skills

• Organization skills, including attention to detail and multitasking
• Communication skills

PC Skills

Knowledge of the MS Office Suite

Proficiency in one or more statistical programming languages (includes SAS)