Lead Statistical Programmer

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

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.