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Director of Biostats

Company: The Ascent Services Group, Inc
Location: Lake Forest
Posted on: May 13, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

  • Necessary processes and procedures for biostatistics; implement and reinforce company-wide
  • Drive functional excellence within the biostatistics discipline by establishing and communicating standards for performance and by effective talent management
  • With cross functional colleagues, establish culture and business practices essential for organizational success, and create and maintain standard operating procedures and standard templates
  • Influence key stakeholders across the organization to achieve R&D and corporate goals, and be sought after internally for statistical expertise
  • Lead direct and indirect reports and liaise with peers at different geographical locations
  • Define requirements for technology and platforms needed to implement and enhance statistics
  • Keep current on developments in statistical methodology; identify innovative statistical techniques and apply them to the clinical development process
  • Utilize natural history data to assist in study design
  • Ensure compliance with applicable regulatory requirements and best practices
  • Hold internal staff and external vendors accountable for quality and timeliness of data management activities supporting teams in clinical development, medical affairs, pharmacovigilance and other organizations across multiple development projects, and ensure all teams are adequately supported
  • Support data managers and programmers to ensure seamless transfer of data within the department
  • Effectively recruit, manage, develop, evaluate, reward, and retain direct reports, and ensure direct reports are compliant with all training requirements, relevant regulatory requirements and corporate and departmental procedures and standards
  • Differentially recognize, develop and reward talent that is critical to and future growth through leadership opportunities and areas of visibility within and external to the company
  • Serve on biometrics leadership team which oversees statistics, data management and statistical programming functions
  • Lead or support continuous improvement initiatives within--and serve as a representative to cross-functional R&D initiatives
  • Enable a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner
  • Provide statistical expertise and leadership, individually and through direct reports, to ensure program objectives are in alignment with regulatory and commercial needs
  • Determine optimal staffing models, as a combination of insourcing and outsourcing, to support Horizon
  • Participate in regulatory (US and ex-US) meetings; lead statistical interaction with regulatory agencies and respond to requests
  • Travel as needed to execute assigned responsibilities and tasks
  • PhD in statistics or related field and at least 12 years of industry experience expected; MS in statistics or related field and at least 15 years of industry experience considered with exceptional record of achievement
  • Proficient in Microsoft Office
  • Strong interpersonal skills
  • Ability to manage and be managed remotely
  • Excellent written and verbal communication skills
  • Demonstrated achievement in development of staff
  • Excellent interpersonal and project management skills
  • Comprehensive knowledge of clinical trials methodology, regulatory requirements, and statistical software packages. Experience with interventional, observational and retrospective studies. Ability to contribute strategically.
  • Demonstrated ability to operate and lead in a matrix organization, building successful working relationships and effective stakeholder management in an environment with multiple lines of authority and competing needs
  • 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
  • Ability to sit and stand for extended periods of time
  • Ability to carry, handle and reach for objects
  • Manual dexterity to operate office equipment, e.g. computer, phones, etc.
  • Manages Ambiguity
  • Strategic Mindset
  • Demonstrates Self-awareness
  • Develops Talent
  • Drives Results
  • Ensures Accountability
  • Decision Quality
  • Courage

Keywords: The Ascent Services Group, Inc, Lake Forest , Director of Biostats, Executive , Lake Forest, California

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