Manager, Statistical Programming (Medtech)

TL;DR

Manager, Statistical Programming (Medtech): Leading a team of statistical programmers to support medical device clinical research with an accent on regulatory submissions, data integrity, and process innovation. Focus on managing resource planning, developing standard programming code (SAS, R, Python), and ensuring compliance with FDA and ICH guidelines.

Location: Must be based in the US. Role is remote with a requirement for willingness to work on-site occasionally and potential for 5-10% business travel.

Salary: $158,000 - $227,000 (Annual Base Salary Range for mid-cost labor market).

Company

hirify.global is a global healthcare company focused on innovative therapies for patients with vascular and neuro conditions.

What you will do

• Select, manage, and develop a team of statistical programmers.
• Lead resource planning and forecasting for internal and external programming resources.
• Oversee the development of analysis datasets, tables, listings, and figures for clinical studies.
• Ensure quality, integrity, and timely delivery of programming deliverables for regulatory submissions.
• Drive the development of standard code (SAS, R, Python, Git) and standard operating procedures.
• Manage CROs and external vendors to ensure project quality and adherence to timelines.

Requirements

• Must be based in the US.
• Bachelor’s degree in Statistics, Data Science, Computer Science, or related field.
• 8+ years of experience in statistical programming, specifically in medical devices or drug development.
• In-depth knowledge of statistical programming concepts and regulatory requirements (e.g., FDA, ICH).
• Technical competence in SAS, R, Python, and Macro development.
• Ability to represent the statistical programming function in cross-functional teams.

Nice to have

• Master’s degree in a relevant field.
• 1+ years of experience in a supervisory role.
• Experience with regulatory filings and clinical trial expectations.
• Strong leadership and interpersonal skills.

Culture & Benefits

• Competitive compensation package including equity program.
• Comprehensive benefits program.
• Opportunity to work in a regulated, high-impact medical device environment.
• Collaborative culture across Statistics, Data Management, and Regulatory teams.