Senior SAS Programming Lead, Clinical Submissions

Acadia Pharmaceuticals; United States; On-site; USD 163,000 - 203,000; Full time

Benefits offered by this job

Competitive base salary

Medical, dental, and vision insurance

401(k) Plan with company match

Employee Stock Purchase Plan

Vacation and holidays

Job summary

Acadia Pharmaceuticals seeks an Associate Director, SAS Programming to lead statistical programming for an assigned compound. You will own strategy, resource planning, and hands-on deliverables, ensuring SDTM/ADaM conformance and submission readiness across studies and CRO partners.

You will drive improvements in programming capabilities, mentor junior staff, and collaborate with Biometrics and cross-functional R&D teams to meet regulatory requirements and timelines.

Qualifications

• Bachelor's degree in statistics, biostatistics, computer science, mathematics, or related field; master's preferred.
• 8+ years of progressively responsible experience in statistical programming with clinical data; lead programmer experience.
• Expert-level SAS programming across Base SAS, SAS/STAT, SAS Macro, ODS, SAS/GRAPH, SQL.
• Deep knowledge of CDISC SDTM/ADaM and electronic submission requirements (FDA/EMA/PMDA).
• Experience with NDA/BLA/MAA submissions and CRO/FSP oversight.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Lead programming for an assigned compound; manage timelines, deliverables, and lead programmers.
• Set programming strategy and standards; design integrated datasets for safety/efficacy analyses.
• Develop and validate SDTM/ADaM programs and contribute to SAPs, CRFs, and data transfer specs.
• Ensure submission readiness of outputs for clinical study reports and health authority responses.
• Oversee vendor qualifications and CRO/FSP partnerships; drive continuous improvement.

Skills

Advanced SAS programming

CDISC SDTM/ADaM

Statistical programming lead

Regulatory submission support

Resource planning

Vendor oversight

Data standards & validation

GCP/ICH/FDA/EMA knowledge

Microsoft SQL/SAS MACRO

R (preferred)

Education

Bachelor's in statistics/biostatistics/computer science

Master's degree preferred

Tools

Pinnacle 21

SAS

Conformance tooling

define.xml tooling

Job description

Acadia Pharmaceuticals seeks an Associate Director, SAS Programming to lead statistical programming for an assigned compound. You will own strategy, resource planning, and hands-on deliverables, ensuring SDTM/ADaM conformance and submission readiness across studies and CRO partners.

You will drive improvements in programming capabilities, mentor junior staff, and collaborate with Biometrics and cross-functional R&D teams to meet regulatory requirements and timelines.