Lead Biostatistician in Oncology and Immunology

2 weeks ago


Philadelphia, Pennsylvania, United States Penfield Search Partners Full time

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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