Statistical Programmer
Katalyst Healthcares and Life Sciences - Bridgewater, New Jersey, us, 08807
Work at Katalyst Healthcares and Life Sciences
Overview
- View job
Overview
Develop and execute modeling-ready analysis and reporting datasets, tables, listings, figures and submission deliverables under the guidance of a senior level programmer. Perform validation tasks according to departmental SOPs and collaborate effectively with outsource partners. ct as a key collaborator with modelers, statisticians, and other project stakeholders to gather and document user requirements for statistical programming deliverables. Programmatically synthesize preclinical data into analysis ready structures from varied data sources. Programmatically develop, validate and maintain modeling-ready datasets by integrating PK, PD and covariate data. Produce tables and graphics for inclusion in study reports and regulatory submissions. Produce SAS transport files and associated documentation for regulatory submissions. ssure deliverable quality and compliance with departmental SOPs and good programming practices. Collaborate effectively with project team members including outsource provider staff. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Requirements:
Must have a master's degree in computer science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field OR a bachelor's degree in computer science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus at least 2 years SAS programming experience in a clinical trial environment. Must possess SAS programming skills including data steps, procedures, SAS/MACRO, SAS/GRAPH. Knowledge and skills in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings); knowledge of pharmaceutical development processes; and knowledge in CDISC SDTM and ADaM standards required. Must possess abilities to quickly and effectively learn new program techniques and data structures; to take direction effectively and complete programming tasks under the guidance of a senior programmer at a project level; and to collaborate with key stakeholders. Must have an interest and ability to work in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; and an interest to advance career by investing in development activities and taking on tasks with increasing levels of challenge and responsibility. Good interpersonal skills and ability to negotiate and collaborate effectively; good written, oral, and presentation skills also required.