Our Principal Biostatisticians provide statistical and development support and influence for client trials, offering expertise in processes, clinical development plans, concept sheets, and protocols. They may also oversee work supported by other vendors.
Responsibilities include:
1. Providing statistical leadership and expertise in clinical development plans, concept sheets, and protocols; representing Cytel on sponsor Product Development Teams.
2. Having experience in Oncology, preferably in hematology and late-phase studies, with prior experience in registrational studies, acting as an independent statistician, participating in study meetings, and discussing statistical analysis plans and health authority questions.
3. Leading statistical teams on clinical development projects, ensuring timely and aligned statistical outputs, and coordinating statistical aspects across trials.
4. Contributing to study protocols, case report forms, data management plans, statistical analysis plans, and performing analyses.
5. Reviewing study reports, regulatory submission sections, and leading electronic data submissions to authorities.
6. Familiarity with ADAM and SDTM, capable of hands-on work to derive outputs or summary statistics quickly.
7. Managing biostatisticians and statistical programmers in lead roles, focusing on strategy, deliverables, and processes.
8. Innovating with statistical methodologies, developing or adapting techniques suitable for each project, and contributing to the company's visibility and expertise.
9. Developing sourcing strategies for projects and fostering collaboration with sponsor teams and management.
An experienced Principal Biostatistician with a passion for clinical development, adept at advanced statistical methods, will lead late-phase Oncology studies, motivate teams, and drive clinical progress. Minimum education required is a Ph.D. or MS in Statistics, Biostatistics, or a related discipline.
Minimum work requirements include:
* At least 6 years of biostatistics experience in pharma/biotech clinical development.
* At least 3 years in a lead biostatistician role.
* Knowledge of international regulatory guidelines, experience with FDA interactions, and data submission.
* Fluency in English; French or German is a plus.
* Proficiency in SAS and CDISC; R experience is advantageous.
Skills required include effective teamwork, customer focus, excellent communication, organization, time management, creativity, leadership, and mentorship abilities.
Working embedded within a pharmaceutical client, you'll be at the forefront of innovation, working autonomously in a dynamic environment dedicated to advancing patient treatment.
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