US - Data Analyst-Sr - Andover - TalentBurst

Description

Data Analyst-Sr/ Clinical Biostatistician

Andover, MA 01810

10 Months

Description:

We are seeking a driven and innovative Lead Statistician to serve as the technical lead for statistical strategy and delivery within the company's Orthopedic Reconstruction & Robotics portfolio, reporting to the Head of Global Data Analytics. This role directly supports high‑impact/complexity studies and provides program‑level and technical leadership across all statistical activities in the business unit. This includes study design, analysis, and interpretation, and ensuring quality, consistency, and scientific rigor across the business unit's portfolio. The Lead Statistician will guide and mentor statisticians within the Orthopedic Reconstruction & Robotics statistics pod, overseeing technical review, resource coordination, and delivery oversight in a matrixed team environment. This individual acts as the statistical authority and thought partner for Orthopedic Reconstruction & Robotics, championing innovative methodologies and ensuring alignment with global clinical and regulatory standards. The successful candidate will be first and foremost a lifelong learner. They will have a strong theoretical foundation in mathematics, clinical biostatistics, and study design methodology, and a true passion for innovation. If this sounds like you, we encourage you to apply

Responsibilities:

Statistical Leadership and Strategy

• Serve as the technical lead and statistical authority for the Orthopedic Reconstruction & Robotics portfolio, providing strategic input across all stages of clinical evidence generation
• Champion innovative statistical methodologies and study designs, fostering consistency, quality, and scientific rigor across programs
• Partner with cross‑functional leadership to ensure statistical approaches are aligned with regulatory expectations, scientific best practices, and business priorities
• Mentor, coach, and perform technical review of the work of statisticians within the Orthopedic Reconstruction & Robotics statistics pod, promoting professional growth and excellence in execution

Study Design and Planning

• Provide expert statistical guidance in the design of clinical studies and registries, including sample‑size estimation, randomization, adaptive and hybrid designs, and simulation‑based planning
• Collaborate with clinical operations, data, medical affairs, and clinical strategy teams to define study type, endpoints, estimands, and analysis frameworks that are robust, transparent, and fit for regulatory submission as applicable

Statistical Analysis

• Oversee the planning and conduct of complex statistical analyses, ensuring appropriate methods are applied (e.g., survival analysis, mixed‑effects models, Bayesian frameworks, causal inference methods, propensity scores)
• Ensure statistical deliverables meet quality and reproducibility standards, performing or delegating technical review as required
• Utilize and guide others in the effective use of SAS, R, and emerging analytical tools, fostering continuous learning and modernization of analytical workflows

Data Management and Quality

• Provide technical oversight of data cleaning, derivation, and integration activities in collaboration with Data Management, Programming, and Data Science teams
• Establish and enforce quality control and validation practices for all statistical deliverables across the Orthopedic Reconstruction & Robotics portfolio

Results Interpretation and Reporting

• Translate complex statistical findings into clear, actionable insights for clinical, regulatory, and executive stakeholders
• Lead or contribute to the statistical content of Clinical Study Reports (CSRs), regulatory submissions, publications, and cross‑portfolio summaries

Thought Leadership and Continuous Improvement

• Maintain awareness of emerging statistical methodologies, regulatory guidance, and data standards relevant to medical device research
• Act as a thought partner and catalyst for innovation, promoting adoption of modern statistical approaches, simulation, and automation in the analysis lifecycle
• Support the development and harmonization of statistical SOPs, best practices, and governance frameworks across Global Clinical and Medical Affairs

Education:

Minimum of a Master's degree (Ph.D. preferred) in Statistics, Biostatistics, Applied Mathematics, or a related quantitative research discipline.

Experience:

A minimum of a Master's and 5 years applied experience, or Ph.D. and 2 years applied experience as a clinical statistician in an academic or industry setting.

• Proven experience leading statistical activities and influencing teams in a matrixed environment
• Demonstrated expertise in study design, advanced modeling, and statistical programming (SAS and R)
• Strong understanding of regulatory and clinical research standards (e.g., FDA ISO 14155, ISO)
• Excellent communication skills, with the ability to clearly and confidently explain statistical reasoning to non‑statistical audiences
• Proven ability to inspire, mentor, and elevate the technical capabilities of peers and junior staff
• Experience with simulation, causal inference, and clinical registry data analysis preferred

Preferred Skills:

• Familiarity with CDISC standards and data integration workflows across studies and clinical evidence sources
• Experience with Bayesian approaches, causal inference frameworks, and propensity‑based methods
• Proficiency in version control (e.g., Git) and modern data science collaboration tools
• Demonstrated ability to drive innovation and modernization in statistical processes or infrastructure
• Relevant domain knowledge in one or more of: medical device robotics, AI‑SaMD, orthopedic reconstruction, or studies with long term (up to 10 years) follow up.