Principal Biostatistician FSP - Late Phase

An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one Phase I-IV clinical studies across your region. 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 clinical development 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: Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.

Responsibilities:

• Provide statistical input into study protocols, Case Report Forms, and data management plans, DMCs and write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
• Incorporate Estimand framework while authoring study documents.
• Create specifications and perform analyses such as time-to-event and longitudinal analysis.
• 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.
• Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

Qualifications:

• PhD in statistics or Master's degree in statistics or related subject required along with clinical trial experience.
• Relevant experience in statistical or biostatistical analysis supporting clinical trial operations for the pharma/biotech industry preferred.
• Understanding of the application of biostatistics to medical/clinical trials data.
• Excellent verbal and written communications skills.
• Ability to organize multiple work assignments and establish priorities.
• Working SAS & CDISC knowledge required. Experience in R is preferred.
• Late Phase (II or III) experience required. Experience with regulatory submissions is a plus.
• Adaptive design, Estimand framework, EAST experience preferred.
• Knowledge of R programming and R Shiny.