The Senior Statistical Programmer is responsible for providing hands‑on support and technical guidance on clinical study teams. The development of study and ad‑hoc output, including, but not limited to: ADaM datasets, tables, figures, and listings output and/or QC of requested output, is the main focus of this role. This individual, working closely with the study statistician, will be responsible for review and acceptance of contract research organization (CRO) deliverables, which are mainly, but not limited to, datasets in submission‑ready standard format (ADaM), tables, figures, and listings, and submission packages. Main Responsibilities and Accountabilities Collaborates with the study statistician to design data structure and specifications for adhoc and study deliverables, including, but not limited to ADaM datasets, Tables, Figures, Listings and Analysis Submission content. Leads the production and validation efforts for the designed output; this may include oversight of work by CROs. Collaborates with peers and statisticians to ensure the quality and accuracy – thus submission readiness – of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml). Supports the review of related deliverables when provided by CROs. Leads requested efforts for pooled and exploratory analyses, working closely with clinical programming team and their collection of legacy data. Leads the in‑house specification and delivery of ISS and ISE datasets and associated output (tables, figures, and listings) when not provided by CRO. Leads the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format. Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group. Works closely with clinical study teams to ensure that project timelines are met with high quality deliverables. Additional tasks Supports C
