Biostatistical Programming Sr Mgr (Clinical Biostatistics)

Location: United States — Remote

Salary: $151,838.05–$205,427.95 annual base salary

Company

hirify.global is a biotechnology company developing and delivering medicines for serious illnesses, including biosimilar products.

What you will do

• Represent biostatistical programming within multidisciplinary project teams and collaborate with biosimilar statisticians, CROs, and other functions.
• Coordinate dataset specifications and implementation of tables, listings, and graphs according to statistical analysis plans, timelines, and work practices.
• Review or contribute to data management plans, database development, edit checks, statistical analysis plans, protocols, clinical study reports, integrated summaries, publications, and related documents.
• Oversee the organization, quality, and timely archiving of statistical outputs, datasets, and documentation.
• Lead technical solutions for CRO programs on hirify.global systems, support submission data packages and ad-hoc analyses, and improve operational efficiency and submission readiness.
• Support CRO policy and SOP development, programmer recruitment, staff development, and adherence to applicable biosimilar development standards.

Requirements

• BA/BSc or higher degree in a quantitative or scientific subject.
• At least 8 years of relevant statistical programming experience in a clinical development environment.
• Excellent oral and written English communication skills.
• Experience working effectively in cross-functional teams.
• Advanced SAS programming skills for clinical data processing, including SAS Base, STAT, Macro, and Graph.
• Working knowledge of current CDISC SDTM, ADaM, and Define-XML standards.
• Ability to lead and manage programmers through the successful and timely completion of project programming activities.
• Ability to perform complex statistical programming and related tasks effectively.

Nice to have

• MSc or higher degree in a quantitative or scientific subject.
• Familiarity with Java or R and in-depth knowledge of SAS Graph, SAS STAT, SAS Macro, and SQL.
• Regulatory submissions experience and experience with data quality and compliance checks such as Pinnacle21.
• Experience working with global teams and CRO partners to improve operational excellence and efficiency.
• Staff development, project management, and training experience.

Culture & Benefits

• Remote work model for the United States, with flexible work models where applicable.
• Health, dental, vision, life, disability, and flexible spending account benefits.
• Retirement and savings plan with company contributions, plus stock-based long-term incentives.
• Discretionary annual bonus program and award-winning time-off plans.
• Career development opportunities and work-life balance support.
• Sponsorship for this role is not guaranteed.

Hiring process

• Applications are accepted until a sufficient number of candidates are received or a candidate is selected; there is no fixed application deadline.