Sr. Data Analyst

job summary:
The Lead Statistician serves as the primary technical authority for statistical strategy and delivery within the Orthopedic Reconstruction & Robotics portfolio. Reporting to the Head of Global Data Analytics, this role provides program-level leadership across high-complexity studies to ensure scientific rigor and the successful navigation of global regulatory landscapes. The incumbent acts as a strategic thought partner, championing innovative methodologies that translate complex clinical data into actionable insights for the advancement of orthopedic surgical care.

location: Andover, Massachusetts
job type: Contract
salary: $65 - 67 per hour
work hours: 9 to 5
education: Masters

responsibilities:

• Strategic Statistical Authority: Serve as the technical lead for clinical evidence generation, providing strategic input across all stages of the portfolio to align statistical approaches with regulatory expectations and business priorities.
• Advanced Study Design: Design robust clinical studies and registries utilizing expert guidance on sample-size estimation, randomization, adaptive/hybrid designs, and simulation-based planning.
• Complex Analytical Oversight: Lead the conduct of sophisticated analyses, including survival analysis, mixed-effects models, and Bayesian frameworks, ensuring all deliverables meet the highest standards of reproducibility and quality.
• Mentorship and Technical Review: Oversee a dedicated statistics pod in a matrixed environment, providing rigorous technical review and fostering professional excellence among junior statisticians.
• Cross-Functional Collaboration: Partner with Clinical Operations, Medical Affairs, and Regulatory teams to define endpoints and estimands that support robust regulatory submissions and high-impact publications.
• Innovation and Harmonization: Maintain a deep awareness of emerging methodologies and regulatory guidance to catalyze the adoption of automation and modern statistical infrastructure across Global Clinical and Medical Affairs.

qualifications:

Qualifications Required:

• Education: Master's degree (Ph.D. preferred) in Statistics, Biostatistics, Applied Mathematics, or a related quantitative research discipline.
• Experience: A minimum of 5 years (for Master's) or 2 years (for Ph.D.) of applied experience as a clinical statistician within an industry or academic setting.
• Technical Proficiency: Demonstrated expertise in advanced modeling and statistical programming using SAS and R.
• Regulatory Knowledge: Deep understanding of clinical research standards, including FDA regulations and ISO 14155.
• Leadership: Proven ability to influence matrixed teams and mentor junior technical staff.

Preferred:

• Methodological Expertise: Experience with Bayesian approaches, causal inference, propensity-based methods, and simulation-based planning.
• Domain Knowledge: Previous experience in medical device robotics, AI-SaMD, or orthopedic reconstruction.
• Data Standards: Familiarity with CDISC standards and version control tools such as Git.
• Clinical Depth: Experience managing clinical registry data and studies with long-term (up to 10-year) follow-up periods.

#LI-BM1

skills: SAS, CDISC, R Language, SAS/STAT, Global Trials, Food and Drug Administration (FDA), FDA Submissions


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.