Associate Director, Biostatistics - MedTech Surgery
Johnson & Johnson
5 months ago
Remote friendly (Raritan, NJ)
United States
Clinical Research and Development
Purpose:
- Lead a team of statisticians for J&J MedTech Surgery, accountable for developing and executing statistical strategy for pre- and post-market clinical trials, 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 line with applicable laws/regulations.
- Provide statistical direction for study design, protocol development, analyses, and publication strategy.
- Partner with trial team and Clinical Operations/Franchise leadership to set priorities and develop project plans (timelines, milestones, budgets).
- Provide input to Clinical Data Management and Programming on adoption of data and programming standards.
- Interact with regulatory agencies to support review of statistical methodology.
- Stay current with statistical research and novel methodology in clinical trial design and analysis.
Qualifications / Requirements:
- Master’s degree in Statistics or related field required; PhD strongly preferred.
- 8+ years (6+ with a PhD) of clinical research experience in Medical Device and/or Pharmaceuticals.
- 3+ years managing direct report FTEs.
- Experience interacting with regulatory agencies.
- Frequentist and Bayesian adaptive designs experience (highly desirable).
- Proficiency in SAS and R/Python.
- Demonstrated technical leadership delivering critical milestones.
- Excellent verbal and written communication skills.
Preferred Skills:
- Advanced Analytics, Analytical Reasoning, Biostatistics, Clinical Data Management, Compliance Management, Data Privacy Standards.
- Good Clinical Practice (GCP), Inclusive Leadership, Program Management, Quality Assurance (QA).
- Regulatory Affairs Management, Standard Operating Procedure (SOP), Statistical Analysis Systems (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 and Family Time (up to 40 hours/year); Parental Leave (480 hours within one year of birth/adoption/foster care).
- Bereavement Leave (240 hours immediate family; 40 hours extended per year); Caregiver Leave (80 hours in 52-week rolling period).
- Volunteer Leave (32 hours/year); Military Spouse Time-Off (80 hours/year).
- Lead a team of statisticians for J&J MedTech Surgery, accountable for developing and executing statistical strategy for pre- and post-market clinical trials, 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 line with applicable laws/regulations.
- Provide statistical direction for study design, protocol development, analyses, and publication strategy.
- Partner with trial team and Clinical Operations/Franchise leadership to set priorities and develop project plans (timelines, milestones, budgets).
- Provide input to Clinical Data Management and Programming on adoption of data and programming standards.
- Interact with regulatory agencies to support review of statistical methodology.
- Stay current with statistical research and novel methodology in clinical trial design and analysis.
Qualifications / Requirements:
- Master’s degree in Statistics or related field required; PhD strongly preferred.
- 8+ years (6+ with a PhD) of clinical research experience in Medical Device and/or Pharmaceuticals.
- 3+ years managing direct report FTEs.
- Experience interacting with regulatory agencies.
- Frequentist and Bayesian adaptive designs experience (highly desirable).
- Proficiency in SAS and R/Python.
- Demonstrated technical leadership delivering critical milestones.
- Excellent verbal and written communication skills.
Preferred Skills:
- Advanced Analytics, Analytical Reasoning, Biostatistics, Clinical Data Management, Compliance Management, Data Privacy Standards.
- Good Clinical Practice (GCP), Inclusive Leadership, Program Management, Quality Assurance (QA).
- Regulatory Affairs Management, Standard Operating Procedure (SOP), Statistical Analysis Systems (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 and Family Time (up to 40 hours/year); Parental Leave (480 hours within one year of birth/adoption/foster care).
- Bereavement Leave (240 hours immediate family; 40 hours extended per year); Caregiver Leave (80 hours in 52-week rolling period).
- Volunteer Leave (32 hours/year); Military Spouse Time-Off (80 hours/year).