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!

Job description

Responsibilities

Lead the development, validation, and maintenance of statistical programs using SAS to generate tables, listings, and figures (TLFs) for clinical trial data analysis.
Develop and maintain SDTM domains in accordance with CDISC guidance.
Create and optimize Adam datasets, Tables, Figures, Listings (TFLs) and Analysis content.
Support the creation of statistical outputs for clinical study reports (CSRs), regulatory submissions, and publications.
Prepare documentation for regulatory submissions, including electronic submissions to the FDA and other global health authorities.
Perform data cleaning, validation, and preparation tasks to ensure high-quality datasets for analysis.
Prepare and maintain thorough documentation of programming activities, including specifications, programming code, and validation reports.

Requirements:

Minimum of a bachelor's degree required; MS degree is preferred (statistics, biostatistics, or closely related field).
5 years' experience with SAS and clinical programming within the biotech / pharmaceutical industry.
Proficiency in SAS programming, including experience with SAS macro language, data step programming, and PROC SQL.
Strong knowledge of CDISC and CDASH standards, including SDTM and Adam datasets, and experience with regulatory submission requirements.
Experience with clinical trial data and understanding of the drug development process.
Knowledge of regulatory guidelines, including FDA, EMA, and ICH, related to statistical programming and clinical trials.
Experience with statistical programming development, validation, execution, maintenance, documentation, and archival of clinical data for regulatory submission is required.

Required profile