What are the responsibilities and job description for the Statistical Programmer position at Katalyst CRO?
Responsibilities
- 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.
- Act 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.
- Assure 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.
- 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.
Principal Statistical Programmer
BioSpace -
Basking Ridge, NJ
