Associate Director, SAS Programming

Acadia Pharmaceuticals Inc.

2d•$162,600 - $203,300•Remote

About The Position

The Associate Director, SAS Programming leads statistical programming for an assigned compound and is accountable for the quality, CDISC conformance, timelines, and submission readiness of deliverables produced internally and by FSP and CRO partners. The role sets compound programming strategy, oversees resource planning and lead programmers, manages vendor programming resources, and remains hands-on with complex, high-impact deliverables. It also contributes to improvements in programming capabilities, departmental standards, and ways of working.

Requirements

Bachelor's degree in statistics, biostatistics, computer science, mathematics, or a related field; an equivalent combination of relevant education and experience may be considered.
Targeting 8 years of progressively responsible experience in statistical programming with clinical data, preferably in pharmaceutical or biotech environments.
Lead programmer experience on more than one study or program and experience overseeing CRO or FSP deliverables.
Expert-level SAS programming skills, including Base SAS, SAS/STAT, SAS Macro, ODS, SAS/GRAPH, and SQL.
In-depth knowledge of CDISC standards, including SDTM, ADaM, controlled terminology, define.xml, and reviewer guides, and ability to write detailed dataset specifications.
Detailed knowledge of clinical trial data, drug development, and regulatory requirements, including GCP, ICH, 21 CFR Part 11, and FDA, EMA, and PMDA electronic submission requirements.
Experience constructing integrated datasets across multiple clinical trials to support integrated summaries of safety and efficacy.
Experience with Pinnacle 21 or equivalent conformance tooling and resolving conformance findings.
Demonstrated ability to set programming strategy across multiple studies, plan resources, and guide lead programmers.
Practical use of generative AI tools to improve programming productivity and quality, with understanding of their limitations and validation expectations for AI-assisted outputs in a regulated environment.
Excellent written and verbal communication skills, including the ability to explain technical concepts clearly and concisely to technical and non-technical stakeholders.
Demonstrated initiative, follow-through, and ability to identify opportunities for improvement and efficiency.
High technical standards and ownership of quality, with care for colleagues, partners, and patients.
Ability to balance competing priorities and deadlines while ensuring timely, high-quality execution.
Willingness and ability to travel domestically and internationally as needed.

Nice To Haves

Master's degree.
SAS certification at the Advanced Programmer level.
Experience supporting NDA, BLA, or MAA submissions, including submission data packages and health authority responses.
Working knowledge of R.

Responsibilities

Lead programming for an assigned compound and coordinate its lead programmers, with accountability for deliverables, timelines, and quality across studies.
Set compound programming strategy, including standards implementation, integrated dataset design, and validation approach.
Develop and maintain compound resource plans and timelines, forecast demand against study and program milestones, identify resource gaps, and recommend internal and external resourcing.
Provide programming input into statistical analysis plans, mock shells, case report form design, annotated CRFs, edit check specifications, and data transfer specifications.
Develop and validate SDTM, ADaM, and TLF programs for high-priority deliverables, including database lock, topline, DSMB/DMC, and submission outputs.
Review SDTM and ADaM specifications for consistency with statistical analysis plans across studies.
Design and program integrated datasets to support integrated safety and efficacy summaries, pooled analyses, and cross-study comparisons.
Define and oversee the compound validation approach, including independent double programming and code review; ensure consistent application by internal, FSP, and CRO programmers; and oversee acceptance of define.xml, cSDRG, ADRG, and conformance reports.
Deliver rapid-turnaround ad hoc analyses for senior leadership, regulatory interactions, and health authority information requests.
Ensure clinical study report, submission, and health authority response deliverables are submission ready and compliant with applicable regulatory requirements and internal SOPs; serve as compound subject matter expert during audits and inspections.
Drive use of the global macro library and departmental standards, partnering with the standards function to address gaps.
Qualify programming vendors and manage CRO and FSP partners against agreed quality and timeline expectations, serving as the primary programming point of contact.
Direct FSP, contractor, and CRO resources supporting assigned work.
Collaborate with the SAS Programming team, Biometrics, and other R&D cross-functional teams to align priorities, timelines, and deliverables.
Communicate status, risks, issues, and decisions proactively and transparently, adapting communications to technical and non-technical audiences and escalating early when needed.
Keep current with industry developments, regulatory guidance, and emerging tools; share insights and contribute to continuous improvement.
Provide technical guidance to FSP programmers, contractors, and CRO partners; contribute to departmental standards, SOPs, and training; and serve as an escalation point for complex programming problems.
Perform other responsibilities as assigned.

Benefits

Competitive base salary, discretionary bonus, and equity awards.
Competitive base, bonus, new hire, and ongoing equity packages.
Medical, dental, and vision insurance.
Employer-paid life, disability, business travel, and EAP coverage.
401(k) plan with a fully vested company match of 1:1 up to 5%.
Employee Stock Purchase Plan with a 2-year purchase price lock-in.
15+ vacation days.
13–15 paid holidays, including office closure between December 24 and January 1.
10 days of paid sick time.
Paid parental leave benefit.
Tuition assistance.