Senior Statistical Programmer

Katalyst CRO; Los Angeles (CA); Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

Katalyst CRO is seeking a Sr. Statistical Programmer in Los Angeles to support biostatistics with analysis datasets, tables, listings, and figures for regulatory submissions and publications.

The role emphasizes SDTM/ADaM standardization, development of templates/macros, and collaboration with cross-functional teams to ensure timely, high-quality deliverables in a regulated environment.

Formación

• 5+ years of statistical programming experience in pharma/biotech.
• Attention to regulatory processes and GLP/GxP expectations.
• Working knowledge of CDISC SDTM/ADaM standards.

Responsabilidades

• Develop and validate SAS programs to generate analysis datasets, tables, listings, and figures.
• Implement and maintain standardized programming templates, macros, and tools.
• Collaborate with statisticians, data managers, and vendors to ensure timely deliverables.
• Review SAPs with biostatisticians and anticipate programming complexities.
• QC and validate datasets and outputs per SOPs and best practices.
• Document activities for reproducibility and regulatory compliance.
• Use version control and structured documentation for audit readiness.
• Contribute to posters, presentations, or ad hoc analyses.

Conocimientos

SAS programming

CDISC SDTM/ADaM

GxP compliance

Regulatory submissions

Educación

Bachelor's degree or higher

Herramientas

SAS

Descripción del empleo

Responsibilities

• The Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials
• This role is key to implementing programming standards and supporting the standardization of CDISC-compliant datasets (e.g., SDTM, ADaM) across clinical programs
• Develop and validate SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) that support clinical trial reporting, regulatory submissions, and publications
• Implement and maintain standardized programming templates, macros, and tools to ensure consistency, efficiency, and compliance across clinical studies
• Contribute to the creation and review of programming specifications for SDTM and ADaM like datasets based on CDISC standards and internal guidelines
• Assist in programming support for data cleaning, interim analyses, medical review, and final study reports
• Collaborate with statisticians, data managers, clinical team members, and external vendors to ensure timely and high-quality deliverables
• Review Statistical Analysis Plans (SAP) with biostatisticians to anticipate any complications or complexities for programming activities
• Perform quality control (QC) and validation of internally and externally developed datasets and outputs, adhering to company SOPs and programming best practices
• Integrate data across multiple studies for pooled analyses, submission packages, or visual summaries to support regulatory filings or internal strategy
• Document all programming activities clearly and thoroughly, supporting reproducibility and regulatory compliance in a validated programming environment
• Use version control systems and structured documentation to support audit readiness and collaborative programming practices
• Contribute to posters, presentations, or ad hoc analyses, including visual data summaries using SAS graphics or other data visualization tools
• Other duties as required

Requirements

• Bachelor's degree or higher in Statistics, Computer Science, Mathematics, Life Sciences, or a related discipline.
• 5+ years of experience in statistical programming within the pharmaceutical, biotechnology, or medical device industry.
• Candidate is a detail-oriented statistical programmer with a strong interest in clinical data analysis, regulatory processes (such as PMA or 510(k) submissions), and continual learning in a regulated environment.
• Understanding of clinical trial design, GxP principles, and FDA/EMA regulatory requirements, particularly for medical device submissions such as PMA and 510(k).
• Familiarity with CDISC standards (SDTM, ADaM); ability to implement standardized datasets in line with internal and industry guidelines.
• Strong attention to detail, problem-solving mindset, and ability to work independently or in a team environment.
• Effective communication skills and a collaborative approach to working with cross-functional teams.