Senior Biostatistics Lead

2 months ago

Durham, North Carolina, United States SDC (Statistics & Data Corporation) Full time

About SDC (Statistics & Data Corporation)

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Our purpose is to partner with sponsors to provide high-quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible.

Our Commitment

We operate as a valued partner to our clients by fulfilling their needs as our own and delivering exceptional results. We provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience.

Our Culture

We are committed to our clients and our employees. We offer strong benefits, including competitive pay, generous time off, attainable career advances, positive work/life balance, and 401k matching (US). This allows us to attract some of the most talented people in the industry.

Job Summary

This person will apply a high level of technical expertise to help guide and develop the more junior biostatistics staff members. They will serve as a lead statistician on clinical studies and provide senior-level peer review of work being accomplished by other biostatisticians in the department.

Key Responsibilities

  • Serve as an internal consultant for biostatistics analysis tools and methods.
  • Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support.
  • Actively support business development in capabilities presentations to prospective and current clients.
  • Effectively manage assigned clinical study budgets for biostatistics analysis support.
  • Develop, coach, and mentor junior biostatistics department personnel.
  • Act as the lead statistician on clinical research projects and help with SAS programming.
  • Provide statistical expertise for study design of clinical trial protocols.
  • Write statistical methods section of the study protocol, as needed.
  • Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed.
  • Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP).
  • Program summary tables, data listings, and graphical representations of clinical trials data.
  • Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data.
  • Prepare/review key sections of clinical study reports and various regulatory documents.
  • Perform statistical QC of all department outputs including analyses and clinical study reports.
  • Provide statistical support to answer questions from external clients (such as FDA, Investigators).
  • Contribute to the development, maintenance, and training of standard operating procedures (SOPs).
  • Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed.
  • Manage biostatistics timelines, budgets, and client expectations.

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