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Senior Statistical Programmer (R)

Katalyst CRO

Role overview

Qualifications

  • BS/MS in Statistics, Biostatistics, Mathematics, or related field.
  • 5+ years of clinical statistical programming with CDISC SDTM and/or ADaM.
  • 2+ years producing clinical outputs in R using pharmaverse, including admiral for ADaM and rtables/tern.
  • Strong R programming skills, including tidyverse, RMarkdown/Quarto, and Git/GitHub.

Responsibilities

  • Develop SDTM datasets from raw EDC data in R (sdtm.oak).
  • Develop and validate ADaM datasets in R (admiral).
  • Produce TLFs in R (rtables/tern) and submission-ready datasets (xportr) for clinical study reports and regulatory submissions.
  • Perform independent QC/double programming of SAS and R outputs.

Key facts

Hard skills

About the company

Katalyst CRO logo

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:
Clinical statistical programmer with hands-on SDTM, ADaM, and TLF production and validation experience in R using pharmaverse packages, supporting an end-to-end R workflow alongside existing SAS code.
Responsibilities:
  • Develop SDTM datasets from raw EDC data in R (sdtm.oak).
  • Develop and validate ADaM datasets in R (admiral).
  • Produce TLFs in R (rtables/tern) and submission-ready datasets (xportr) for clinical study reports and regulatory submissions.
  • Perform independent QC/double programming of SAS and R outputs.
  • Collaborate with biostatisticians and study teams on SAPs, specs, and timelines.

Requirements:

  • BS/MS in Statistics, Biostatistics, Mathematics, or related field.
  • 5+ years of clinical statistical programming with CDISC SDTM and/or ADaM.
  • 2+ years producing clinical outputs in R using pharmaverse, including. admiral for ADaM and rtables/tern (or similar TLF packages like gtsummary or Tplyr).
  • R outputs produced for actual study deliverables (e.g., CSR, DSMB, or interim analyses).
  • Strong R programming skills, including tidyverse, RMarkdown/Quarto, and Git/GitHub.
  • SAS experience, to work alongside existing SAS code.

Preferred Qualifications:

  • sdtm.oak and xportr experience.
  • R outputs used in a regulatory submission.

Nice to Have:

  • Shiny app development, including user access control (e.g., rAccess, shinymanager, Posit Connect).

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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