Associate Director, Biostatistics – MedTech Surgery
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Job Description
Associate Director leading Biostatistics team for J&J's MedTech Surgery group. Ensuring the execution of statistical strategy for clinical trials with a focus on integrity and compliance.
Responsibilities:
- 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
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