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Celldex

Senior Director of Biostatistics (Needham)

Celldex, Needham

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The Senior Director, Biostatistics will play a critical leadership role and participate in developing and implementing the strategic plans for Celldex Therapeutics clinical developments by using expertise in statistics, design and analysis of clinical trials, and data analytics and mining through cross-functional collaboration and decision-making process. The Senior Director of Biostatistics will provide technical support for ongoing clinical trials, FDA submissions, publications and other business needs. This position reports to the head of Biostatistics and Data Management and can be located at Needham, MA office.
Responsibilities
Key responsibilities of this role include but are not limited to:

  • Accountable for leading the biostatistics strategy in one or several Celldex Therapeutics clinical development project(s).
  • Provide statistical leadership into clinical development plans, protocol development, statistical analysis results, and other product support initiatives
  • Provide oversight of CRO and statistical vendors externally to ensure quality of all statistical deliverables and adherence to requirements/timeline.
  • Collaborate effectively cross-functionally (e.g., with clinical research, regulatory strategy, data management, statistical programming, medical writing etc.) to facilitate the implementation of statistical analyses, provide statistical input to the CSR and scientific presentations/manuscripts, perform statistical functions for submission related activities and serve as internal statistical expert in the overall program.
  • Develop and implement department standards, processes and practices to ensure statistical integrity of project deliverables.
  • Develop and mentor junior statisticians to help grow the department.
  • Develop functional biostatistics infrastructure and capabilities.
  • Identify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making.
Qualifications
  • D. in Statistics, Biostatistics, Mathematics or related field.
  • 15+ years of experience in pharmaceutical/biotech clinical drug development. Past NDA/BLA submission experience is preferred.
  • Proficiency in statistical programming languages/software such as SAS, R, etc.
  • Extensive knowledge of FDA/ICH guidelines and CDISC standards/implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines; In-depth knowledge of the global drug development process.
  • Demonstrated written and oral communication skills and ability to work within a team and work independently are required.
  • Other important requirements include interdependent/analytic thinking skills, building strategic working relationships, and good decision-making capability.
  • Desire to work in a fast-paced, innovative environment
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.

Seniority level

  • Seniority level

    Director

Employment type

  • Employment type

    Full-time

Job function

  • Job function

    Research, Analyst, and Information Technology

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