Senior SAS Programmer

RESPONSIBILITIES:

Provide subject matter expertise in designing and developing clinical trials, protocols, and case report forms.

Offer technical support and expert advice to internal and external sponsors.

Lead and influence ongoing clinical studies by supporting statistical and non-statistical analyses.

Implement programming and project standards in accordance with the Statistical Analysis Plan.

Act as a liaison between clinical management, subcommittees, and project teams.

Use efficient programming techniques to produce and quality-check derived datasets, tables, figures, and data listings.

Convert program specifications into SAS code for datasets and outputs.

Lead overall project delivery, including clinical trial reports and regulatory submission deliverables.

Create statistical analysis outputs for final reports, abstracts, posters, manuscripts, and other clinical publications.

Assist in establishing standardized programming procedures and work instructions.

Develop, evaluate, and validate standardized macros and utility programs.

Assist in developing client proposal documents.

Provide leadership, project management, and resource management for programming tasks supporting clinical trial activities.

Provide input into statistical programming timelines and negotiate timelines.

Mentor statistical programmers and provide input into documents produced by other functions.

Keep updated on statistical programming techniques and technical advancements.

Interact with regulatory agencies regarding electronic submission specifications.

Monitor project resourcing, budgets, and scope changes.

Ensure the quality, traceability, and timeliness of programming deliverables.

Participate in process/quality improvement initiatives.

Provide consultancy to internal and external sponsors on statistical programming tasks.

Ensure compliance with relevant regulatory requirements.

EDUCATION:

Bachelor’s degree in Computer Science, Mathematics, Statistics, Life Sciences, or related field.

EXPERIENCE:

Minimum of 6 years of experience using SAS® in clinical trials data analyses.

Exposure to CDISC (SDTM and ADaM) is a plus.

SKILLS:

Expertise in SAS/BASE, SAS/STAT, 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.

Strong organizational and time management skills.

Consistent experience as a lead statistical programmer.

Excellent analytical and presentation skills.

Proven ability to learn new systems and function in an evolving technical environment.

Ability to negotiate, influence, and create strategies to improve efficiency.

Business awareness and financial acumen.

Ability to work effectively in a quality-focused environment.