Planet Pharma · 18 hours ago
Data Analyst-Sr
Andover, MA
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expPlanet Pharma is seeking a driven and innovative Lead Statistician to serve as the technical lead for statistical strategy and delivery within their Orthopedic Reconstruction & Robotics portfolio. This role involves providing strategic input across clinical evidence generation stages, mentoring statisticians, and ensuring alignment with regulatory standards while championing innovative methodologies.
BiotechnologyHealthcarePharmaceuticalHealth Care
Responsibilities
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 technical review the work of statisticians within the Orthopedic Reconstruction & Robotics statistics pod, promoting professional growth and excellence in execution
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
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
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
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
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
Qualification
Required
Minimum of a Master's degree (Ph.D. preferred) in Statistics, Biostatistics, Applied Mathematics, or a related quantitative research discipline
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
Preferred
Experience with simulation, causal inference, and clinical registry data analysis preferred
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
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase