Job Description Who Are You? An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one or multiple medical affairs projects. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push forward to what it could be. You motivate others to do the same.

Sponsor-dedicated Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview As a Principal Biostatistician, you are responsible for statistical activities in support of medical affairs projects, including study designs, study protocol and analysis plan development, reviewing and interpreting the analysis of study data, and conducting ad hoc and exploratory analyses, working on publications

Responsibilities As a Principal Biostatistician, your responsibilities include:

• Provide statistical leadership and statistical expertise into medical affairs study plans, concept sheets and protocols, represent Cytel and the statistical team on the Development Teams of sponsors.
• Lead statistical teams on clinical development projects, ensuring alignment of objectives and delivery of statistical output on time and meeting project requirements, coordinating all statistical aspects across of each assigned project.
• Provide statistical input into study protocols, Case Report Forms, and data management plans, write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
• Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
• When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.
• Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her/his expertise and customer orientation.
• Contribute to the development of sourcing strategy for projects.
• Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

Qualifications What we’re looking for:

• Minimum Education: Ph.D. or MS in Statistics, Biostatistics or related discipline.

• Minimum Work Requirements:

• Minimum of 5 years' experience in biostatistics/statistics with substantial experience in pharmaceutical or biotech clinical development

• Strong programming skills in SAS and/or R, including development and validation of tables, listings, and figures (TLFs) and creation of reusable macros

• Demonstrated experience performing QC/peer review and validation of SAS and/or R programs

• Ability to QC, author, and implement Statistical Analysis Plans (SAPs) with minimal oversight

• Experience producing statistical study reports and presenting/communicating results clearly to clinical and cross‑functional teams

• Expertise reviewing and contributing to statistical sections of study protocols

• Proficiency with CDISC SDTM and ADaM standards

• Solid understanding of clinical trial design and analysis methods

• Skills:

• Prior experience in CNS therapeutic area would be plus

• Excellent programming skills in SAS and/or R, including development and validation of tables, listings, and figures (TLFs) and creation of reusable macros

• Excellent written and verbal communication skills and ability to work effectively in cross‑functional teams

• Experience with adaptive designs, real‑world evidence analyses would be plus

• PhD in Biostatistics, Statistics is plus