Associate Director, SAS Programming

About this role

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.

Position Summary
The Associate Director, SAS Programming is an exciting opportunity to take a leading role in statistical programming for an assigned compound, with accountability for the quality, CDISC conformance, and submission readiness of deliverables produced internally or by FSP and CRO partners. The role provides the opportunity to set compound programming strategy, own resource planning, and stay hands-on with complex, high-impact deliverables. In addition to leading day-to-day delivery, this individual will help drive meaningful improvement initiatives that advance programming capabilities and ways of working across the organization.
Primary Responsibilities
Deliverables and Quality

• Serves as programming lead for an assigned compound, accountable for deliverables, timelines, and quality across its studies, and coordinates the lead programmers assigned to it.

• Sets compound programming strategy, including standards implementation, integrated dataset design, and validation approach.

• Develops and maintains compound resource plans and timelines, forecasts demand against study and program milestones, identifies gaps, and recommends internal and external resourcing.

• Provides programming input into statistical analysis plans, mock shells, case report form design, annotated CRFs, and edit check and data transfer specifications.

• Performs hands-on development and validation of SDTM, ADaM, and TLF programs for high-priority deliverables across the compound, including database lock, topline, DSMB/DMC, and submission outputs.

• Reviews SDTM and ADaM specifications for consistency with the statistical analysis plan across studies, so derivations are interpreted the same way across the compound.

• Designs and programs integrated datasets across studies to support integrated summaries of safety and efficacy, pooled analyses, and cross-study comparisons.

• Defines the compound validation approach, including which outputs need independent double programming and which need code review, ensures internal, FSP, and CRO programmers apply it consistently, and oversees acceptance of define.xml, cSDRG, ADRG, and conformance reports.

• Delivers rapid-turnaround ad hoc analyses for senior leadership, regulatory interactions, and health authority information requests.

• Ensures deliverables for clinical study reports, submissions, and health authority responses are submission ready and compliant with GCP, ICH, 21 CFR Part 11, FDA, EMA, and PMDA requirements, and internal SOPs, and serves as subject matter expert for the compound during audits and inspections.

• Drives use of the global macro library and departmental standards, partnering with the standards function on gaps.

Vendor Oversight

• Performs vendor qualification for programming services and manages CRO and FSP partners for the compound against agreed quality and timeline expectations, serving as the primary programming point of contact.

• Directs FSP, contractor, and CRO resources supporting assigned work.

Collaboration, Initiative, and Growth

• Collaborates closely within the SAS Programming team, across Biometrics, and with other R&D cross-functional teams to align on priorities, timelines, and deliverables.

• Communicates proactively and transparently on status, risks, issues, and decisions, adapting the message for technical and non-technical audiences and escalating early when needed.

• Keeps current with industry developments, regulatory guidance, and emerging tools through conferences, professional forums such as PHUSE, PharmaSUG, and CDISC, and continuous self-learning, and shares insights with the team to drive continuous improvement.

• Provides technical guidance to FSP programmers, contractors, and CRO partners, contributes to departmental standards, SOPs, and training, and serves as an escalation point for complex programming problems.

• Other responsibilities as assigned.

Education/Experience/Skills

• Bachelor's degree in statistics, biostatistics, computer science, mathematics, or a related field; master's degree preferred. SAS certification at the Advanced Programmer level preferred. 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 a pharmaceutical or biotech environment, including lead programmer experience on more than one study or program and oversight of CRO or FSP deliverables.

• Expert-level SAS programming, 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 the ability to write detailed dataset specifications.

• Detailed knowledge of clinical trial data, the drug development process, 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 resolution of conformance findings.

• Demonstrated ability to set programming strategy across multiple studies, plan resources, and guide…