Mid-level Biostatistician/Epidemiologist � Real World Evidence (RWE), Regulatory and Life Sciences Research - Remote, US

Introduction

At Slipstream IT we work to streamline IT Support and provide managed solutions with a strategic consulting and global leadership management approach. Our solutions are designed exclusively for emerging pharma and biotech organizations.

Slipstream�s industry-leading solutions free clients from the demands of internal IT and allow them to rapidly advance their mission. Led by a leadership team that has been together for over 10 years, you will join a proven team, culture, and strategy to drive innovation within the IT outsourcing industry while developing your skillset with the opportunities for internal growth.

Job Overview

The Biostatistician/Epidemiologist will have a proven track record of leading the design and statistical analysis of RWE studies. Experience with regulatory randomized controlled trials is also desired but not required. Proficiency in SAS programming and experience with R is required. This role supports RWE strategy and regulatory submissions by developing statistical analysis plans, programming specifications, and high-quality results for protocols using real-world data sources such as electronic health records (EHR), claims data, registries, and other non-interventional datasets.

Responsibilities & Duties

• Lead statistical design, analysis, and reporting of regulatory studies integrating RWE.
• Develop statistical analysis plans (SAPs), table shells, and outputs aligned with regulatory expectations.
• Generate and QC regulatory-quality outputs (including RWE study reports, briefing packages, and FDA submissions).
• Apply appropriate statistical methods for comparative effectiveness, natural history, safety, and burden-of-illness studies.
• Create and validate SAS code to support RWE analyses and ensure data traceability and reproducibility.
• Collaborate with cross-functional teams including medical writers, clinicians, clients and regulators.
• Ensure adherence to internal SOPs, ICH guidelines, FDA RWE guidance, and other global regulatory standards.

Qualifications

• Education level: MS or Doctoral degree in a Biostatistics, Statistics, Epidemiology, or a related quantitative field.
• Experience: At least 7 years of experience in biostatistics/epidemiology using RWD.
• Strong knowledge of real-world data sources, study design principles (eg, retrospective cohorts, propensity scores, IPTW), and causal inference methodologies.
• Experience preparing regulatory-grad documents and output submitted to health authorities is desired but not required.
• Proficient in SAS programming, including macros, statistical procedures, and dataset manipulation.
• Excellent communication skills.
• High level of collaborativeness to effectively work across teams.
• Due to the remote nature of work, individuals must be driven to meet timelines without direct oversight.
• Travel: Up to 5% for FDA meetings

Part Time Hourly Pay Rate

• $130/hr-$140/hr.

Slipstream IT is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation or identity, national origin, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Slipstream IT makes hiring decisions based solely on qualifications, merit, and business needs at the time.

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.