Senior/Principal Biostatistician

• Today

Katalyst CRO

Role overview

Qualifications

Master's in Statistics, Biostatistics, or related field with 5+ years of experience in the design, analysis, and reporting of clinical studies.
PhD in a related field with 3+ years of experience
Demonstrated experience in SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data.
Significant experience working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets.

Responsibilities

Supporting Phase 2 or 3 studies
Hands-on with data checking
Programming and statistical analysis deliverables under guidance

Key facts

Remote from: New Jersey (USA)
Full time
Senior (5-10 years)
Biostatistician
English

Hard skills

About the company

Katalyst CRO

Contract Research Organizations (CRO)

Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. With a strong foundation in cGxP & ICH-GCP-compliant clinical research, we offer fully customizable, end-to-end solutions, covering everything from pre-clinical studies to Phase I–IV clinical trials, regulatory affairs, and validation services—ensuring seamless drug and device development. Our Expertise Across the Product Lifecycle: 🔹 Pre-Clinical Research & Development – In-Vitro (Lab-Based) & In-Vivo (Animal) Studies 🔹 Clinical Research & Development – Trial Management, Data Management, Biostatistics, Medical Writing, Pharmacovigilance 🔹 Regulatory & Quality Compliance – cGxP (GMP, GLP, GCP) Validations, Regulatory Affairs, Process & System Validations 🔹 Strategic Human Resourcing – Connecting top-tier talent to life sciences and healthcare organizations With deep industry expertise and a flexible, client-centric approach, Katalyst CRO leverages an advise-build-operate model to de-risk and accelerate research programs. We help organizations achieve regulatory success, optimize quality systems, and bring life-changing therapies to market faster—ultimately improving global patient health and safety. 💡 Partner with Katalyst CRO to bring breakthrough therapies to market with confidence. 📩 Let’s connect and shape the future of healthcare together!

Company details

IndustryContract Research Organizations (CRO)

Company size51 - 200

Links

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Job description

Summary:

The senior/principal biostatisticians will be supporting Phase 2 or 3 studies and be hands-on with data checking, programming, and statistical analysis deliverables under guidance.

Qualifications:

Master's in Statistics, Biostatistics, or related field with 5+ years of experience in the design, analysis, and reporting of clinical studies.
OR
PhD in a related field with 3+ years of experience
Demonstrated experience in SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data.
Significant experience working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets.

About the company

Katalyst CRO

Contract Research Organizations (CRO)

Company details

IndustryContract Research Organizations (CRO)

Company size51 - 200

Links

Website LinkedIn See all jobs

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