Principal Biostatistician FSP - Late Phase Oncology

As a Principal Biostatistician, you are responsible for statistical activities in support of Oncology late phase clinical trials, including study designs, study protocol and analysis plan development, reviewing and interpreting the analysis of study data, and conducting ad hoc and exploratory analyses. **As a Principal Biostatistician, your responsibilities 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. + 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. **What we're looking for:** + **Minimum Education: Ph.D. or MS in Statistics, Biostatistics or related discipline.** + **Minimum Work Requirements:** + At least 6 years of experience as biostatistician in the Pharmaceutical/Biotechnology industry in clinical development. + At least 3 years of experience as a Lead Biostatistician for clinical development projects. + Knowledge of relevant international regulatory guidelines applicable to clinical development, and some experience of regulatory interactions and data submission to FDA. + Fluent in English + Working SAS & CDISC knowledge. + **Skills:** + Works effectively in international teams, effectively operates within a matrix organization and with multi-disciplinary groups. + Understands and anticipates customer needs and responds to their inquiries. + Oncology late phase trials experience + Strong validation skills and experiences in ADaM/output QC, good knowledge of SDTM, eCRF + Experience in writing SAP. + Can work independently with minimal oversight + Multiple myeloma trials experience and submission experiences are preferred. + Verbal and written communication is effective with multi-disciplinary groups. + Work is well-organized, of high-quality, meeting timelines. Able to balance concurrent tasks and responsibilities. + Excellent time management. + Brings creative ideas and makes suggestions for optimization. + Exhibits leadership for the biostatistics team working on the same clinical development teams. + Exhibits the ability to mentor and develop statistical colleagues. Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.