Lead Biostatistician in Oncology and Immunology
2 weeks ago
Company Overview: Penfield Search Partners is a prominent player in the field of biostatistics, specializing in the advancement of therapies within Oncology and Immunology. Our client is dedicated to pioneering drug development programs that encompass a wide array of therapeutic strategies.
Position Summary: We are in search of experienced Statisticians at the project level who will play a crucial role in supporting drug development initiatives across various phases. This position is open for candidates at the Senior or Principal level, depending on their expertise.
Key Responsibilities:
- Collaborate with multidisciplinary project teams to define and establish project timelines.
- Provide statistical insights for study protocols.
- Draft comprehensive statistical analysis plans.
- Oversee internal and CRO project activities, ensuring adherence to timelines and deliverables.
- Guide and mentor programming teams in the creation of analysis dataset specifications and the programming of tables, listings, and figures.
- Analyze study outcomes and review statistical summary reports for precision.
- Contribute to the writing of relevant sections in clinical study reports.
- Engage in the development of Clinical Development Plans.
- Participate in pre-IND and NDA processes.
- Assist in the formulation and implementation of SOPs and guidelines.
Qualifications:
- Ph.D. in Statistics is required.
- Fewer than 4 years of experience in the pharmaceutical or biotechnology sectors, with a comprehensive understanding of biostatistics.
- Proven ability to work autonomously in project management and decision-making roles.
- Strong communication skills to effectively convey ideas and manage programming teams constructively.
- Proficiency in SAS for conducting efficacy analyses and validating critical data derivations when necessary.
- Experience with Health authorities, particularly in discussions and negotiations regarding filing strategies, is highly advantageous.
- Familiarity with multivariate analyses and biomarker analyses is a plus.
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