Associate Director, Biostatistics – MedTech Surgery

Job Description: • Provide leadership and direction for Biostatistics, including management and mentoring of staff to provide expert statistical capability. • Develop and maintain 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