Position Summary
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 lead programmers.
- Experience supporting NDA, BLA, or MAA submissions, including submission data packages and health authority responses, is preferred.
- Working knowledge of R is preferred.
- Practical use of generative AI tools to improve programming productivity and quality, with an understanding of their limitations and the validation expectations for AI-assisted outputs in a regulated environment.
- Excellent written and verbal communication skills, with the ability to convey technical concepts clearly and concisely to technical and non-technical stakeholders.
- Demonstrated initiative: recognizes what needs to be done, acts without waiting to be asked, follows through to results, and identifies opportunities for improvement and efficiency.
- Brings competence and care to the work: high technical standards and ownership of quality, combined with genuine care for colleagues, partners, and the patients behind the data.
- Balances competing priorities and deadlines, ensuring timely and high-quality execution.
- Willingness and ability to travel domestically and internationally as needed.
Physical Requirements
This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.
What we offer US-based Employees:
- 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
EEO Statement (US-based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
California Applicants: Please see Additional Information for California Residents within our Privacy Policy.
Canadian Applicants: Please see Additional Information for Canadian Residents within our Privacy Policy.
Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia within our Privacy Policy.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in the absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.