Associate Director

Associate Director, Statistical Programming The Lotus Group is partnering with a commercial-stage biopharmaceutical company to identify an Associate Director of Statistical Programming. This is a hands‑on leadership position supporting clinical development programs from study execution through regulatory submission. The Associate Director will lead statistical programming activities, oversee work performed by external partners and contribute directly to SAS programming when needed. The position will also help strengthen programming standards, processes and tools across the Biometrics organization. Key Responsibilities Plan and execute statistical programming activities for clinical studies, including timelines, deliverables and quality oversight. Develop and review SAS programs supporting analysis datasets, tables, listings, figures and clinical study reports. Translate statistical analysis plans into programming specifications and analysis deliverables. Support exploratory analyses, publications, internal data reviews, regulatory interactions and post-hoc requests. Review study documentation and data structures, including case report forms, database specifications and data-transfer requirements. Provide technical review of SDTM and ADaM specifications, analysis plans and output shells. Evaluate CRO programming deliverables for accuracy, completeness, compliance and adherence to agreed timelines. Perform independent validation of datasets and statistical outputs produced by external partners. Assess clinical data packages for CDISC compliance and regulatory submission readiness. Use industry‑standard validation tools to investigate findings and support preparation of reviewer documentation. Create reusable SAS macros, utilities and programming tools. Establish or improve programming conventions covering validation, documentation, reuse and archival. Coordinate internal programming resources and external vendors across assigned studies. Contribute to Biometrics standards, governance and operational process improvements. Monitor evolving regulatory expectations and industry standards affecting clinical statistical programming. Qualifications Bachelor’s degree in statistics, mathematics, computer science, engineering, life sciences or a related quantitative discipline; master’s degree preferred. Approximately 10 or more years of statistical programming experience supporting clinical drug development in sponsor companies. Advanced SAS programming expertise, including Base SAS, SAS Macro, SAS/STAT and SAS/GRAPH. Strong working knowledge of CDISC standards, particularly SDTM and ADaM. Experience preparing or reviewing submission‑ready clinical data packages, including define.xml and associated reviewer documentation. Strong proficiency with Pinnacle 21 or comparable data-validation tools. Demonstrated experience overseeing statistical programming work performed by CROs or other external partners. Experience managing study‑or program‑level statistical programming deliverables. Understanding of clinical trial design, clinical data structures, statistical analysis methods and standard safety and efficacy outputs. Ability to explain technical programming or data issues clearly to non-programming stakeholders. Ability to work independently, establish priorities and solve problems in an evolving environment. Willingness to remain technically engaged and contribute directly when project needs require it. Additional Experience That Would Be Valuable Statistical programming experience supporting late‑stage clinical trials. Experience contributing to FDA, EMA or other health‑authority submissions. Experience working with data from complex clinical development programs. Familiarity with R, R Shiny, Spotfire, Tableau or related visualization tools. Experience improving departmental programming standards, infrastructure or reusable tools. #J-18808-Ljbffr The Lotus Group LLC