Job Title: Associate Director Data Standards & Statistical Programming Job Description The Associate Director of Data Standards & Statistical Programming is tasked with planning and tracking statistical programming activities, including SAS macro development at both the program and study levels. This role is pivotal in overseeing and managing the workflow of clinical data listings, summary tables, figures, and Define.xml files. The position supports Biostatistics and Data Management teams to ensure standard operating procedures (SOPs) and departmental resources are kept current. Responsibilities + Plan and track statistical programming activities, including SAS macro development at both program and study levels. + Coordinate tasks across multiple studies within a program, collaborating with CRO, Biostatistics, and Data Management on key deliverables. + Ensure the latest CDISC standards are implemented and adhered to. + Design, develop, and validate computer programs to analyze clinical data. + Define departmental standards and SOPs and manage the workflow of clinical data listings, summary tables, figures, and Define.xml files. + Mentor junior programmers assigned to the project. + Manage all statistical programming activities at program and study levels. + Oversee the work of programmers to ensure high-quality and accurate results. + Act as a liaison between Statistical Programming, Data Management, and Biostatistics to optimize workflow and outcomes. + Exercise independent judgment in developing SOPs, Work Instructions, and Processes to produce high-quality results. + Perform statistical analysis to interpret clinical trial results. + Create SDTM, ADaM, SAS transport files, Define.xml, Pinnacle 21 reports, and reviewer guides for electronic submissions worldwide. + Generate safety and efficacy tables, listings, and graphs using Base SAS, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS. + Develop dataset specifications and review TLF Shells. + Review Data Management Plan, Data Validation Plan, and edit check specifications. Essential Skills + MS in Mathematics, Statistics, Computer Science, or equivalent. + 12+ years of statistical programming experience in the Bio-Pharma industry using SAS for clinical trial data analysis in Phase I/II/III trials. + At least 8 years of experience using CDISC SDTM and ADaM standards. + Minimum of 4 years of experience in oncology clinical trials, using RECIST to derive key primary and secondary endpoints. + Experience in developing datasets and outputs for integrated summaries (ISE/ISS) as a statistical programming lead on NDA filings. + At least 4 years of experience in fast-paced small or medium biotech environments. + Solid knowledge of SAS programming language, with strong skills in SAS Base, SAS/Macros, SAS/Graph, and SAS/Stat. + Proficiency in SAS programming and statistical experience Additional Skills & Qualifications + Knowledge of R programming and/or Python is a plus. Work Environment This position offers a remote work environment based in the Pacific Standard Time (PST) zone. Job Type & Location This is a Contract position based out of South San Francisco, CA. Pay and Benefits The pay range for this position is $95.00 - $115.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Feb 19, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.