Associate Director, SAS Programming

🔥 20 minutes ago

🇺🇸 United States – Remote

💵 $162.6k - $203.3k / year

⏰ Full Time

🟠 Senior

👔 Director

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Acadia Pharmaceuticals Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1993

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

💰 $287.5M Post-IPO Equity on 2019-09

Healthcare • Pharmaceuticals • Biotechnology

Acadia Pharmaceuticals Inc. is a pharmaceutical company specializing in breakthroughs in neuroscience to enhance lives. For over 30 years, Acadia has been at the forefront of healthcare, pioneering treatments for conditions like Parkinson’s disease psychosis and Rett syndrome. The company's focus is on developing innovative and novel medicines that address unmet medical needs, especially in therapeutic areas with high demand, such as Prader-Willi syndrome, Alzheimer’s disease psychosis, and other central nervous system disorders. Acadia is dedicated to elevating life by embracing diverse perspectives, fostering collaboration, and advancing scientific research and development.

📋 Description

• Serve as programming lead for an assigned compound, accountable for deliverables, timelines, and quality across studies. • Coordinate lead programmers assigned to the compound. • Set compound programming strategy, including standards implementation, integrated dataset design, and validation approach. • Develop and maintain resource plans and timelines; forecast demand, identify gaps, and recommend resourcing. • Provide programming input into statistical analysis plans, mock shells, CRF design, annotated CRFs, and data specifications. • Perform hands-on development and validation of SDTM, ADaM, and TLF programs for high-priority deliverables. • Review SDTM and ADaM specifications for consistency across studies. • Design and program integrated datasets for safety and efficacy summaries, pooled analyses, and cross-study comparisons. • Define and oversee validation approaches and acceptance of define.xml, cSDRG, ADRG, and conformance reports. • Deliver ad hoc analyses for senior leadership, regulatory interactions, and health authority requests. • Ensure clinical study reports, submissions, and health authority responses are submission-ready and compliant with applicable requirements. • Serve as compound subject matter expert during audits and inspections. • Drive use of global macro libraries and departmental standards. • Qualify and manage CRO and FSP programming partners. • Direct FSP, contractor, and CRO resources. • Collaborate with SAS Programming, Biometrics, and R&D teams. • Communicate status, risks, issues, and decisions, escalating early when needed. • Provide technical guidance and contribute to standards, SOPs, and training. • Serve as an escalation point for complex programming problems.

🎯 Requirements

• Bachelor's degree in statistics, biostatistics, computer science, mathematics, or a related field; master's degree 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. • 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. • 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. • Experience with Pinnacle 21 or equivalent conformance tooling. • Ability to set programming strategy across multiple studies, plan resources, and guide lead programmers. • Practical use of generative AI tools in a regulated environment. • Excellent written and verbal communication skills. • Ability to balance competing priorities and deadlines. • Willingness and ability to travel domestically and internationally as needed.

🏖️ Benefits

• 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 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 24th and January 1st • 10 days of paid sick time • Paid parental leave benefit • Tuition assistance

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