Senior SAS Statistical Programmer Lead

Katalyst CRO; San Francisco (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Katalyst CRO in San Francisco is seeking an experienced Lead Statistical Programmer to lead programming for regulatory submissions, create datasets, tables, listings and figures, and ensure on-time delivery.

You will mentor junior programmers, collaborate with biostatisticians and data managers, develop standardized macros, SDTM/ADaM mappings, define.xml, and support CDISC standards in a fast-paced CRO environment.

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 CFR Title 21, Part 11 for electronic records and signatures.
• Good organizational skills across projects and timelines, ability to manage multiple assignments.
• Consistent experience as a lead statistical programmer on concurrent projects.
• Strong understanding of drug development and cross-functional interfaces.
• Strong mentoring and leadership for projects and junior staff.
• Excellent analytical skills.
• Ability to learn new systems in evolving environments.
• Ability to negotiate, influence, and present to stakeholders.
• Business and financial awareness relevant to projects.
• Ability to define strategies to improve trial efficiency.
• Work in a quality-focused environment.
• Knowledge of other programming languages and databases is a plus.

Responsibilities

• Convert specifications into SAS code to generate datasets and TLF outputs.
• Be responsible for overall project delivery, including regulatory submissions.
• Create statistical outputs for final reports, abstracts, posters, manuscripts, and publications.
• Assist in establishing standardized programming procedures and work instructions.
• Develop, enhance, and validate standardized macros and utilities for regulatory compliance.
• Develop and maintain clinical processing workflow systems.
• Assist in developing client proposal documents.
• Provide leadership, training, stakeholder management, sponsor support, resource management, and project management for programming tasks.
• Provide input into and manage timelines for statistical programming; lead a team to complete studies on time and within budgets.
• Train sponsor SOPs and disseminate knowledge to project teams.
• Provide input into, and mentor programmers on documents produced by other functions (e.g., biostatistics, data management, medical writers); records handling per CFR and e-submission guidance.
• Assist in updating PROMETRIKA SOPs.
• Develop SAS tools for data analysis and reporting compliant with regulatory requirements.
• Develop specifications (metadata) and annotate CRFs; map raw data to CDISC SDTM standards.
• Create define.xml files from metadata for SDTM/ADaM.
• Convert data from other formats to SAS datasets.

Skills

SAS/BASE

SAS/STAT

SAS/CONNECT

SAS/ACCESS

SAS/MACRO

SAS/GRAPH

SQL

ODS

Job description

Katalyst CRO in San Francisco is seeking an experienced Lead Statistical Programmer to lead programming for regulatory submissions, create datasets, tables, listings and figures, and ensure on-time delivery.

You will mentor junior programmers, collaborate with biostatisticians and data managers, develop standardized macros, SDTM/ADaM mappings, define.xml, and support CDISC standards in a fast-paced CRO environment.