Xeris Pharmaceuticals, Inc. · 2 months ago
Associate Director, Biostatistics and Statistical Programming
US-IL-Chicago
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$140K/yr - $240K/yr
6+ years expXeris Pharmaceuticals, Inc. is seeking an Associate Director, Biostatistics and Statistical Programming to drive biostatistical activities in support of drug product development. The role involves contributing to study design, protocol development, and ensuring compliance with regulatory requirements while overseeing outsourced statistical activities.
BiotechnologyDiabetesHealth CarePharmaceuticalTherapeutics
Responsibilities
Conducts basic statistical analysis of study data with minimal supervision according to a statistical analysis plan to generate results and insights used to support study findings
Applies moderately advanced statistical methods, which may include simulation models and other statistical programming as needed, with guidance
Generates sample size and power calculations and randomizations
Oversees the review of statistical documents and operational activities outsourced to CROs ensuring adherence to cost, timeline, and data quality requirements to ensure that the analysis plans use the most appropriate statistical methods and that the data displays such as tables/figures/listings are accurate and complete
Programs or independently validates key study results to support interpretation of data
Provides statistical programming support to other clinical studies or regulatory submissions where another biostatistician is assigned as the sponsor lead
Works closely with Data Management by providing input to data management-related documents and assisting with data review and cleaning activities, as needed
Ensures compliance of data packages to regulatory requirements and CDISC and industry standards
Assists in the development of abstracts, manuscripts, presentations for scientific congresses
Closely collaborates and participates in knowledge sharing with other team members including non-statisticians to assist with interpretation and understanding of results
Qualification
Required
MS/MPH degree in biostatistics, statistics, or epidemiology
A minimum of six years of clinical trial experience as a statistician and/or statistical programmer in the pharmaceutical, biotech, or CRO industry
Experience in Phases I-III of the clinical drug development process
Knowledge and basic understanding of statistical concepts and techniques commonly applied to the analysis of data from clinical trials and the ability to tackle from basic to moderately complex statistical or data issues
Basic understanding of real-world data and observational studies
SAS programming experience required
Working knowledge of CDISC standards
Competencies: Attention to Detail, Organizational skills, Adaptability, Multi-Tasking, Strong Written & Verbal Communication skills, Teamwork & Collaboration, Critical Thinking, Problem Solving, Presentation Skills
Preferred
Prior use and implementation of sample size and power calculation software (e.g., nQuery and PASS)
R experience is a plus
Working knowledge of EDC systems
Benefits
Eligibility for bonus and equity
Multiple paid time off benefits
Various health insurance options
Retirement benefits
Company
Xeris Pharmaceuticals, Inc.
We're a growth-oriented biopharmaceutical company improving patient lives by developing and commercializing advanced products across a range of therapies.
201-500 employees
H1B Sponsorship
Xeris Pharmaceuticals, Inc. 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
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$548.5MKey Investors
Hayfin Capital ManagementArmistice CapitalDeerfield
2024-03-06Post Ipo Debt· $200M
2022-01-03Post Ipo Equity· $30M
2021-03-11Post Ipo Equity· $27M
Leadership Team
John Shannon
CEO and Director
Kenneth Johnson
Senior Vice President - Clinical Development, Regulatory Affairs, QA and Medical Affairs
Recent News
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2026-01-03
2025-12-01
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