Lead Analyst - Biostatistician, Real-World Evidence

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.

Essential Duties & Responsibilities (detailed descriptions):

• 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 SAS programs to generate tables, listings, and figures and analysis datasets.

• Develop programs/macros to automate standard analyses and reduce programming time. 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

• 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.

What You Need:

Qualification

• 5-8 years of experience as a statistician and/or statistical programmer with at least 2+ years relevant experience with 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 (e.g., R, STATA, python, SQL, Power BI, Tableau, Databricks) and 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 preferred. 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.