Associate Director, Biostatistics - MedTech Surgery
Johnson & Johnson
5 months ago
Remote
United States
Clinical Research and Development
Associate Director, Biostatistics (MedTech Surgery) — Remote (US) option may be considered case-by-case and if approved by the Company.
Purpose
- Lead a team of statisticians for J&J MedTech Surgery; accountable for development and execution of statistical strategy for pre- and post-market clinical trials across the Franchise, ensuring scientific integrity while meeting timelines and budgets.
You Will Be Responsible For
- Provide leadership and direction for Biostatistics, including management and mentoring.
- Develop and maintain global harmonized Biostatistics processes and procedures in accordance with applicable laws and regulations.
- Provide statistical direction for study design, protocol development, analyses, and publication strategy.
- Partner with trial teams and leadership in Clinical Operations/Franchise to set priorities and develop project management plans (timelines, milestones, budgets).
- Provide input to Clinical Data Management and Programming on data and programming standards.
- Interact with regulatory agencies regarding review of statistical methodology used in clinical trials.
- Stay current on statistical research and novel methodology for clinical trial design and analysis.
Qualifications / Requirements
- Master’s degree in Statistics or related field required; PhD strongly preferred.
- 8+ years clinical research experience (6+ with PhD) in Medical Device and/or Pharmaceuticals.
- 3+ years managing direct report FTEs.
- Experience interacting with regulatory agencies.
- Frequentist and Bayesian adaptive design experience (highly desirable).
- Proficient in SAS and R/Python.
- Demonstrated technical leadership delivering critical milestones.
- Excellent verbal and written communication.
Preferred Skills
- Advanced Analytics, Analytical Reasoning, Biostatistics, Clinical Data Management, Compliance Management, Data Privacy Standards, Developing Others, Good Clinical Practice (GCP), Inclusive Leadership, Leadership, Program Management, Quality Assurance (QA), Regulatory Affairs Management, SOPs, SAS Programming, Survey Design, Team Management.
Benefits (time off)
- Vacation: 120 hours/year; Sick time: 40 hours/year (Colorado: 48; Washington: 56); Holiday pay incl. Floating Holidays: 13 days/year; Work/Personal/Family Time: up to 40 hours/year; Parental Leave: 480 hours within one year; Bereavement Leave: 240 hours (immediate family) / 40 hours extended family per year; Caregiver Leave: 80 hours in a 52-week rolling period; Volunteer Leave: 32 hours/year; Military Spouse Time-Off: 80 hours/year.
Purpose
- Lead a team of statisticians for J&J MedTech Surgery; accountable for development and execution of statistical strategy for pre- and post-market clinical trials across the Franchise, ensuring scientific integrity while meeting timelines and budgets.
You Will Be Responsible For
- Provide leadership and direction for Biostatistics, including management and mentoring.
- Develop and maintain global harmonized Biostatistics processes and procedures in accordance with applicable laws and regulations.
- Provide statistical direction for study design, protocol development, analyses, and publication strategy.
- Partner with trial teams and leadership in Clinical Operations/Franchise to set priorities and develop project management plans (timelines, milestones, budgets).
- Provide input to Clinical Data Management and Programming on data and programming standards.
- Interact with regulatory agencies regarding review of statistical methodology used in clinical trials.
- Stay current on statistical research and novel methodology for clinical trial design and analysis.
Qualifications / Requirements
- Master’s degree in Statistics or related field required; PhD strongly preferred.
- 8+ years clinical research experience (6+ with PhD) in Medical Device and/or Pharmaceuticals.
- 3+ years managing direct report FTEs.
- Experience interacting with regulatory agencies.
- Frequentist and Bayesian adaptive design experience (highly desirable).
- Proficient in SAS and R/Python.
- Demonstrated technical leadership delivering critical milestones.
- Excellent verbal and written communication.
Preferred Skills
- Advanced Analytics, Analytical Reasoning, Biostatistics, Clinical Data Management, Compliance Management, Data Privacy Standards, Developing Others, Good Clinical Practice (GCP), Inclusive Leadership, Leadership, Program Management, Quality Assurance (QA), Regulatory Affairs Management, SOPs, SAS Programming, Survey Design, Team Management.
Benefits (time off)
- Vacation: 120 hours/year; Sick time: 40 hours/year (Colorado: 48; Washington: 56); Holiday pay incl. Floating Holidays: 13 days/year; Work/Personal/Family Time: up to 40 hours/year; Parental Leave: 480 hours within one year; Bereavement Leave: 240 hours (immediate family) / 40 hours extended family per year; Caregiver Leave: 80 hours in a 52-week rolling period; Volunteer Leave: 32 hours/year; Military Spouse Time-Off: 80 hours/year.