Director/Associate Director Biostatistics

Permanent

Penfield Search Partners

Our client is a clinical-stage, public biopharmaceutical company focused on advancing new therapies in the Inflammatory and Autoimmune therapeutic areas. With several compounds in the clinic, they are growing quickly and currently have a need for a Director of Biostatistics to be responsible for providing strategic, scientific, and statistical leadership. This role can also be filled at the Associate Director level, depending on experience. This position reports to the SVP, Biometrics and Data Management.

In this role you will ensure programs meet scientific, regulatory, and quality requirements and are aligned with long-term development goals, through interactions with leadership and members of other functions (e.g., Clinical Development, Clinical Operations, Regulatory Affairs). You will provide hands-on support for study design, statistical analysis, and reporting of data and will plan, organize, coordinate, and review Biostatistics activities. In addition, you will contribute to development strategies aligned to organizational goals including innovative and relevant statistical designs and will provide statistical expertise for regulatory documents, key decisions and scientific communications. In this visible role you will have the opportunity to participate in a team of life science professionals who value science, data, and a high work ethic.

 

  • Provide statistical expertise to new drug development programs as a Subject Matter Expert in Biostatistics
  • Be a thought leader in Statistics, providing leadership and hands-on expertise in statistical methods, regulatory guidelines (FDA, EMA, ICH, etc.), program strategies, clinical development planning, and study designs in multiple Autoimmune and Inflammatory indications
  • Represent the Biostatistics and Programming functions to ensure coordination and alignment across Biometrics functions on program strategies and deliverables
  • Ensure the quality of statistical input and show the ability to integrate expertise across Biostatistics components internally and externally
  • Be accountable for team’s statistical support including experimental design, protocol development, sample size estimation, statistical analysis plan development, patient randomization, case report form design, statistical analyses, and presentation of data
  • Ensure the team maintains consistent analytical approaches and reporting formats within and across studies
  • Research and apply new statistical procedures as needed. Initiate and drive innovation by implementing innovative and relevant designs in the support of program strategy
  • Establish and maintain effective working relationships with vendors, internal coworkers, and project teams
  • Provide statistical input for regulatory submissions; respond to statistical questions raised by regulatory agencies and institutional review boards

Desired for the role:

• Ph.D. or M.S. in statistics, Biostatistics; PhD preferred

• 8+ years with Ph.D. or 10+ years with an MS in the biotech/pharmaceutical industry

• Strong and established track record of developing and establishing statistical excellence

• Experience leading Biostatistics function supporting NDA and EMEA filings

• Comprehensive knowledge of clinical trials methodology, drug development process, regulatory requirements, statistics, and statistical software packages, including SAS

• Experience with protocol development, clinical study reporting, ISS/ISE requirements, and regulatory submissions in paper and electronic format is essential

• Ability to translate clinical study designs into statistical practice and educate study team members in the use of statistics

• Ability to influence and communicate across functions

• Proven strong leadership and project management skills. Demonstrated ability in managing internal and external functional/multi-functional teams and/or initiatives.

• Strong interpersonal and communication skills (verbal and written) bridging scientific and business needs – integrating quantitative sciences, strong disease area knowledge, and appropriate market/competitive intelligence

• Demonstrated ability to evaluate the business impact of decisions, follow through on agreed-upon decisions, and remain flexible when needed

• Excellent analytical, problem-solving, and organization skills with the ability to work on multiple tasks

• Ability to communicate technical information to non-scientists, and willingness to educate the internal team

• Strong team player with excellent collaboration skills

• Outstanding problem-solving skills

Tagged as: Director/Associate Director, Biostatistics