Senior Manager Biostatistics – Remote


Penfield Search Partners

Contact: Mark Maurer –

Job Description: The primary role of this position is to provide statistical support for multiple clinical studies across all phases of clinical development.  Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff.


  • Support biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs, and Business Development
  • Provide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needs.
  • Serve as primary author for statistical sections of protocol.
  • Create accompanying statistical documents (e.g., statistical analysis plan and mocked shells)
  • Participate in development of EDC database and interactive response technology (IxRS) specifications
  • Collaborate with project management, regulatory, medical affairs, PV/safety, business development, and commercial functions
  • Implement innovative statistical techniques that will provide benefit to company clinical development programs
  • Contribute to strategic planning and go/no go decision guidance
  • Review biostatistics and statistical programming tasks outsourced to vendors
  • Perform statistical analyses and create statistical text for clinical publications and other communications, perform SAS programming validation if needed
  • Support the preparation of regulatory submissions documents including summaries of clinical safety and efficacy of BLA/NDAs if needed
  • Ensure timeliness and quality of deliverables
  • Travel as needed to execute assigned responsibilities and tasks

Qualifications and Skills Required:

  • PhD in statistics or related field and at least 3 years of industry experience or MS in statistics or related field and at least 5 years of industry experience.
  • Comprehensive knowledge of clinical trials methodology (experience with Bayesian methods preferred), regulatory requirements, and proficient SAS programming skills and experience with other statistical software packages. Ability to contribute strategically.
  • Proficient in Microsoft Office
  • Professional, proactive demeanor
  • Excellent written and verbal communication skills
  • Experience with people management and development of staff
  • Excellent interpersonal and project management skills
  • Able to collaborate effectively with internal and external study management teams to meet project timelines
  • Must be solution-oriented and willing to educate study team members in appropriate interpretation of designs and results.


Tagged as: Senior Manager, Biostatistics - REMOTE