Bio Statistician, Clinical Research

Key Skills

Biostatistics, Cloud computing, Databricks, PowerBI, R Programming, SAS, Statistics, statsmodels, Tableau

Job Description

Who We Want

• Analytical problem solvers: People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

• Dedicated achievers: People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

• Curious learners: People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.

• Goal-oriented engineers: Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

• Effective communicators: People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

What you will do

This position leads in-house statistical and analytical services in RWE studies, participates in RWE projects within Clinical Affairs and takes part in cross-divisional collaborations with RWE relevance. Working with key stakeholders, the role will execute on key RWE deliverables, establish standards and drive automation for programming of statistical outputs, and demonstrate best practices with regard to transparency and reproducibility of statistical methods and processes used in RWE projects.

• Contribute to the development of RWE study design and protocols

• Create and/or oversee development of statistical analysis plans (SAPs) for RWE studies

• Perform the statistical programming and analyses for assigned RWE studies; write and validate programs to generate tables, listings, and figures and analysis datasets.

• Develop programs/macros to automate standard analyses and increase efficiencies

• Contribute to the development of RWE document templates and standards, and other project deliverables..

• Document projects in sufficient detail for reproducibility

• Oversee external contractors and vendors supporting statistical and programming aspects of RWE projects.

• Train and support onboarding of new hires and mentor junior staff.

• Contribute to knowledge sharing among statisticians and with internal partners

• Increase knowledge of statistical methods relevant to RWE and their implementation

• Identifies areas of improvement with RWE statistical workflows and data quality, and works to improve efficiencies and effectiveness

• Ensure processes (SOPs) and subsequent documentation of statistical process is maintained.

• Participate in cross-functional/cross-divisional initiatives regarding RWE

What You need

Master's Degree or Equivalent in Statistics

• 4+ years of experience as a statistician and/or statistical programmer with at least 2+ years direct experience using observational/real-world data (RWD) in the pharmaceutical or medical device sector.

• Thorough understanding of statistical, pharmacoepidemiology, and outcomes research methods used in real-world evidence (RWE) studies, including medical device surveillance/safety, observational and retrospective database studies, and healthcare utilization.

• Demonstrated experience of leading analyses for RWE studies to meet regulatory requirements within the agreed upon budget, timeline, and resources.

• Experience with advanced statistical methods utilized for RWE studies (e.g., propensity score matching) and eagerness to continuously learn and expand statistical expertise.

• Expert in SAS programming. Working knowledge of other statistical/programming/reporting tools is an advantage (e.g., R, STATA, python, SQL, Power BI, Tableau, Databricks), familiarity with cloud computing.

• Experience with secondary data sources including registries, billing data, claims data, and EMR data. Previous experience using the Premier Healthcare Database is required. Knowledge and/or hands on experience with large healthcare databases (e.g., Truven MarketScan, Optum Clinformatics) and other data models (e.g., OMOP, CDM).

• Familiarity with relevant medical coding vocabularies (e.g., ICD, CPT, HCPCS, LOINC)

• Well-developed interpersonal skills and the ability to work well independently as well as with colleagues and customers.

• Strong organizational skills, with ability to effectively and efficiently handle multiple tasks simultaneously, with precision, and adapt to changes in responsibilities and workloads.

• Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic.

• Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA and GDPR guidelines, and other confidential information.

• Certification in Research HIPAA, Good Clinical Practice, Human Subject Protection, Healthcare Quality Principles preferred.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.