Associate Director, SAS Programming

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the programming lead for a designated compound, responsible for deliverables, timelines, and quality across studies.

• Coordinate the efforts of lead programmers assigned to the compound.

• Establish the programming strategy for the compound, including the implementation of standards, design of integrated datasets, and validation methodologies.

• Create and uphold resource plans and timelines; predict demand, identify deficiencies, and suggest resourcing solutions.

• Provide programming insights for statistical analysis plans, mock shells, CRF design, annotated CRFs, and data specifications.

• Engage in hands-on development and validation of SDTM, ADaM, and TLF programs for critical deliverables.

• Review SDTM and ADaM specifications to ensure consistency across studies.

• Design and program integrated datasets for safety and efficacy summaries, pooled analyses, and cross-study comparisons.

• Define and supervise validation strategies and acceptance criteria for define.xml, cSDRG, ADRG, and conformance reports.

• Deliver ad hoc analyses for senior leadership, regulatory interactions, and health authority requests.

• Ensure that clinical study reports, submissions, and health authority responses are ready for submission and adhere to relevant requirements.

• Act as the subject matter expert for the compound during audits and inspections.

• Promote the use of global macro libraries and departmental standards.

• Evaluate and manage CRO and FSP programming partners.

• Direct resources from FSP, contractors, and CROs.

• Collaborate with SAS Programming, Biometrics, and R&D teams.

• Communicate project status, risks, issues, and decisions, escalating concerns early as necessary.

• Provide technical expertise and contribute to the development of standards, SOPs, and training materials.

• Serve as an escalation point for complex programming challenges.

⛳️ Requirements

• Bachelor's degree in statistics, biostatistics, computer science, mathematics, or a related discipline; a master's degree is preferred.

• An equivalent combination of relevant education and experience may be accepted.

• Aiming for 8 years of progressively responsible experience in statistical programming with clinical data, ideally in a pharmaceutical or biotech setting.

• Experience as a lead programmer on multiple studies or programs, with oversight of CRO or FSP deliverables.

• Proficient in SAS programming at an expert level, including Base SAS, SAS/STAT, SAS Macro, ODS, SAS/GRAPH, and SQL.

• Comprehensive knowledge of CDISC standards, including SDTM, ADaM, controlled terminology, define.xml, and reviewer guides.

• Detailed understanding of clinical trial data, the drug development process, and regulatory requirements, including GCP, ICH, 21 CFR Part 11, and electronic submission standards of the FDA, EMA, and PMDA.

• Experience in constructing integrated datasets across various clinical trials.

• Familiarity with Pinnacle 21 or equivalent conformance tools.

• Ability to define programming strategies across various studies, plan resources, and guide lead programmers effectively.

• Practical experience with generative AI tools within a regulated setting.

• Exceptional written and verbal communication skills.

• Capability to manage competing priorities and meet deadlines.

• Willingness and ability to travel domestically and internationally as required.

🏝️ Benefits

• Competitive base salary, bonuses, and equity packages for new hires and ongoing employees.

• Medical, dental, and vision insurance coverage.

• Employer-funded 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 featuring a 2-year purchase price lock-in.

• More than 15 vacation days.

• 13 to 15 paid holidays, including an office closure from December 24th to January 1st.

• 10 days of paid sick leave.

• Paid parental leave benefits.

• Tuition assistance programs.