Lead biostatistical strategy and execution for pharmaceutical clinical trials, including development plans, protocols, statistical analysis plans, analyses, regulatory submissions, and clinical data submissions. Manage statistical teams and coordinate deliverables across late-phase drug development projects. Collaborate with sponsor biostatistics, clinical, and cross-functional teams, support regulatory interactions, and contribute to sourcing strategies. Gastrointestinal trial experience and strong SAS or R skills are valuable.
Who Are You?
As a Principal Statistician, you will be dedicated to one of our major Pharma clients, working as an extension of their staff to lead and support clinical trials for drug development, with the opportunity to leverage your experience in late-phase trials and regulatory submissions for Gastrointestinal studies.
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.
As a Principal Biostatistician, your responsibilities will include:
- Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product 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 clinical trials 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.
- Contribute to the development of sourcing strategy for projects.
- Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
Qualifications
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
- Master’s degree in statistics or a related discipline. Ph.D. strongly desired.
- 6+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
- At least 3 years of recent experience on late-phase (II & III) drug development including drafting SAPs/calculating sample size/reviewing TLFs
- When in the lead role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.
- Experience in Gastro-intestinal studies or submission is a plus
- Strong knowledge of pharmaceutical industry and regulatory environment preferred
- Strong SAS and/or R programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.
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