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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Biostatisticsstatistical methodologystudy designprotocol developmentdata analysisSASRPythonfrequentist designbayesian adaptive design

Soft Skills

leadershipmentoringcommunicationproject managementteam collaborationstrategic planningproblem-solvinginterpersonal skillstechnical leadershiporganizational skills

Certifications

Master’s degree in StatisticsPhD in Statistics or related field