Lead Statistical Programmer

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

Responsibilities

• Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs.
• Be responsible for overall project delivery, including clinical trial reports and other regulatory submission deliverables.
• Create statistical analysis outputs to be used in support of final reports, abstracts, posters, Manu scripts, and other clinical publications; support systems to produce electronic regulatory submissions.
• Assist in establishing standardized programming procedures and work instructions.
• Develop, enhance, evaluate, and validate standardized macros and utility programs to ensure that regulatory requirements are met through validation/compliance activities.
• Develop and maintain clinical processing workflow systems.
• Assist in the development of client proposal documents.
• Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.
• Provide input into and negotiate statistical programming timelines. Ensure that timelines are adhered to and coordinate and lead a statistical programming team to successful completion of a study within given timelines and budgets.
• Trained in sponsor SOPs and disseminate knowledge to project team members as appropriate.
• Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) records handling (e.g., Chapter 21 of the US Code of Federal Regulation - Part and electronic submission of clinical data to agencies (e.g., e-CTD guidance and CDISC SDTM and ADaM standards).
• Assist in updating/writing PROMETRIKA standard operating procedures (SOPs).
• Develop tools in SAS for data analysis and reporting that comply with regulatory requirements.
• Develop specifications (e.g., metadata files), annotate CRFs and create SAS programs for the mapping of raw datasets to CDISC SDTM standards.
• Create define.xml files from metadata files for SDTM and ADaM.
• Convert data received in other formats to SAS datasets.

Requirements

• 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 Code of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records and electronic signatures in computer systems.
• Good organizational skills across individual projects and managing own and teamwork loads. Ability to organize, manage and complete multiple assignments with challenging timelines independently and effectively.
• Consistent experience as a lead statistical programmer on several concurrent projects.
• Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions.
• Strong mentoring skills as shown by leadership of projects and if applicable, junior team members.
• Excellent analytical skills.
• Proven ability to learn new systems and function in an evolving technical environment.
• Ability to negotiate and influence to achieve results.
• Good presentation skills.
• Good business awareness/business development skills (including financial awareness).
• Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
• Work effectively in a quality-focused environment.
• Knowledge of other programming languages and database management software packages is a plus.