Lead Statistical Programmer — Clinical Trials & Regulatory Analytics

Katalyst CRO; Newark (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking an experienced Senior Statistical Programmer to drive programming tasks for clinical trial analyses and regulatory submissions. You will convert specifications into SAS code, generate datasets and outputs, and ensure quality across deliverables.

You will lead a programming team, mentor junior staff, and collaborate with biostatistics, data management, and medical writing to meet timelines and regulatory requirements.

Qualifications

• Expertise in SAS/BASE, SAS/STAT and knowledge of SAS/CONNECT, SAS/ACCESS, SAS/MACRO, SAS/GRAPH, SQL, and ODS.
• Knowledge of SDTM, ADaM, FDA and ICH guidance.
• Understanding CFR Title 21 Part 11 for electronic records and electronic signatures.
• Strong organizational skills across multiple projects and timelines.
• Proven lead statistical programmer on concurrent projects.
• Strong mentoring and leadership abilities.
• Excellent analytical skills.
• Ability to learn new systems in an evolving technical environment.
• Ability to negotiate and influence to achieve results.
• Good presentation and business awareness.
• Ability to create and define strategies to improve clinical trial efficiency.
• Work effectively in a quality-focused environment.
• Knowledge of other programming languages and database management software is a plus.

Responsibilities

• Convert specifications into SAS code to generate datasets, tables, listings, and figures.
• Oversee project delivery including clinical trial reports and regulatory submissions.
• Create statistical analysis outputs for final reports, abstracts, posters, manuscripts and submissions.
• Develop standardized programming procedures and work instructions.
• Develop, enhance, validate standardized macros and utilities to meet regulatory requirements.
• Develop and maintain clinical processing workflow systems.
• Assist in developing client proposals and project plans.
• Provide leadership, training, stakeholder management, and sponsor support for programming tasks.
• Input into timelines, coordinate and lead a statistical programming team to meet study deadlines and budgets.
• Mentor junior programmers and disseminate knowledge on sponsor SOPs and CDISC standards.
• Support documents produced by other functions (biostatisticians, data managers, etc.) and ensure proper records handling.
• Assist in updating PROMETRIKA SOPs and create mapping specifications to SDTM/ADaM.
• Create define.xml from metadata and convert external data formats to SAS datasets.

Skills

Leadership

Mentoring

Project management

Regulatory knowledge

Tools

SAS/Base

SAS/STAT

SAS/CONNECT

SAS/ACCESS

SAS/MACRO

SAS/GRAPH

SQL

ODS

Job description

Katalyst CRO is seeking an experienced Senior Statistical Programmer to drive programming tasks for clinical trial analyses and regulatory submissions. You will convert specifications into SAS code, generate datasets and outputs, and ensure quality across deliverables.

You will lead a programming team, mentor junior staff, and collaborate with biostatistics, data management, and medical writing to meet timelines and regulatory requirements.