Job Description:
• Provide leadership and direction for Biostatistics, including management and mentoring of staff to provide expert statistical capability.
• Develop and maintains global harmonized processes and procedures for Biostatistics according to applicable laws and regulations.
• Provide statistical direction to staff for study design, protocol development, analyses and publication strategy.
• Work with trial team, and leadership in Clinical Operations and Franchise to set priorities, develop project management plans for trial execution including timelines, milestones, and budgets.
• Provide input to Clinical Data Management and Programming leadership on the adoption of data and programming standards.
• Interact with regulatory agencies to support the review process of statistical methodology employed in clinical trials.
• Stay current with statistical research and the use of novel methodology in clinical trial design and analysis.
Requirements:
• Minimum of Master’s degree in Statistics or related field of study required; PhD strongly preferred.
• Minimum 8+ years (6+ years with a PhD) of experience in clinical research within Medical Device and/or Pharmaceuticals sector.
• At least 3+ years of experience managing direct report FTEs required.
• Experience interacting with regulatory agencies required.
• Experience with frequentist and bayesian adaptive designs highly desirable.
• Proficient in SAS and R/Python programming.
• Demonstrated technical leadership in delivering critical milestones.
• Excellent verbal and written communication skills.
Benefits:
• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year