Lead Statistical Programmer - Clinical Trials

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

Job summary

Katalyst CRO is seeking an experienced Lead Statistical Programmer to convert specifications into SAS code, manage regulatory deliverables, and oversee a project team. You will develop SDTM/ADaM mappings, create define.xml files, and ensure adherence to CFR Title 21 Part 11 in electronic submissions.

The role requires strong mentoring, comprehensive SAS expertise, and the ability to drive timelines across multiple concurrent projects within a quality-focused environment. Newark, NJ on-site.

Qualifications

• Must have 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 of CFR Title 21, Part 11 for electronic records and signatures.
• Strong organizational skills across projects and ability to manage multiple assignments with challenging timelines.
• Consistent experience as a lead statistical programmer on several concurrent projects.
• Strong mentoring and leadership of projects and, if applicable, junior team members.
• Excellent analytical skills.
• Ability to learn new systems in an evolving technical environment.
• Ability to negotiate and influence to achieve results.
• Good presentation skills.
• Good business awareness/business development skills.
• Ability to create, maintain and define strategies to improve clinical trial efficiency.
• Work effectively in a quality-focused environment.
• Knowledge of other programming languages and database management software packages is a plus.

Responsibilities

• Convert specifications into SAS code to generate datasets, tables, listings, and figures outputs.
• Be responsible for overall project delivery, including clinical trial reports and regulatory submission deliverables.
• Create statistical analysis outputs to support final reports, abstracts, posters, manuscripts, and other publications; support systems for electronic submissions.
• Assist in establishing standardized programming procedures and work instructions.
• Develop, enhance, evaluate, and validate standardized macros and utility programs to meet regulatory requirements.
• Develop and maintain clinical processing workflow systems.
• Assist in developing client proposal documents.
• Provide leadership, project training, stakeholder management, sponsor support, resource management, and project management for programming tasks.
• Provide input into and negotiate statistical programming timelines and lead a team to successful study completion within timelines and budgets.
• Train sponsor SOPs and disseminate knowledge to project team members.
• Provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers) and ensure records handling per CFR 21 Part 11.
• Assist in updating PROMETRIKA SOPs.
• Develop SAS tools for data analysis and reporting that comply with regulatory requirements.
• Develop specifications and metadata, annotate CRFs, and map raw datasets to CDISC SDTM standards.
• Create define.xml files from metadata for SDTM and ADaM.
• Convert data from other formats to SAS datasets.

Skills

SAS/BASE

SAS/STAT

SAS/CONNECT

SAS/ACCESS

SAS/MACRO

SAS/GRAPH

SQL

ODS

Tools

CDISC SDTM

ADaM

Job description

Katalyst CRO is seeking an experienced Lead Statistical Programmer to convert specifications into SAS code, manage regulatory deliverables, and oversee a project team. You will develop SDTM/ADaM mappings, create define.xml files, and ensure adherence to CFR Title 21 Part 11 in electronic submissions.

The role requires strong mentoring, comprehensive SAS expertise, and the ability to drive timelines across multiple concurrent projects within a quality-focused environment. Newark, NJ on-site.