Associate Director, Statistics

8 hours ago

Florham Park, New Jersey, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Associate Director, Statistics to join our team at BioSpace, Inc. This role will provide statistical support across a broad range of nonclinical areas with a focus on Chemistry, Manufacture and Control (CMC), expanding and broadening the application of Biostatistics.

Key Responsibilities
  • Apply statistical techniques to facilitate better decision-making and improve business operations.
  • Regularly interact with management of different levels in strategy meetings, contributing to strategic planning to ensure statistically optimized non-clinical development plans and assist in the creation of strategic objectives for regulatory filings.
  • Participate in the planning/design, conduct, analysis, and interpretation of CMC studies and regulatory submissions, establishing departmental and nonclinical SOPs and guidelines.
  • Develop statistical tools to streamline process development, QC testing, and troubleshooting, collaborating with colleagues from other departments to ensure compliance with regulations and help implement regulatory initiatives such as Quality by Design and process validation.
  • Prepare statistical courses and provide training to scientists, mentor junior staff, proactively help with both their technical and career development, and seek general feedback and technical input from colleagues.
  • Develop and deliver statistical and scientific publications and present internally and externally, collaborating with other statisticians in improving and sharing statistical approaches.
  • Maintain and expand expertise in various computing tools to leverage internal and external data sets to drive decisions, examples of such tools include R, Spotfire, SAS, etc.
Qualifications
  • MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field.
  • High degree of technical competence and excellent communication skills, both oral and written.
  • Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others.
  • Able to manage project timeline and quality of deliverables.
  • Able to build strong relationship with peers and cross-functional partners to achieve higher performance.
  • Have strong leadership skills and experience in working/managing cross-cultural or oversea teams.
  • Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.
  • (SSG) Experience leading safety-related projects (eg, ISS, benefit-risk assessment, signal detection).
  • (GMA Stat) Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming.

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