• Generate biological data and genomic data results through project reports including derived analysis datasets, tables, listings and figures (TLFs) based on the Statistical Analysis Plan
(SAP) of the clinical study using SAS;
• Produce figures using other statistical software such as S-plus, generate data definition tables (DDTs), and create SAS Macros to produce output efficiently as needed;
• Determine whether statistical methods are appropriate based on the needs of the research projects; produce derived analysis datasets to meet CDISC SDTM and ADaM data standards;
• Understand and follow DeltaMed Solution’s internal or client programming standards;
• Review the clinical study protocol, case report form (CRF), and SAP and understand the clinical study design;
• Provide strategy and guidance, as well as hands on support, with clinical assay development and validations for clinical testing to ensure a consistent approach to analyses that meets
regulatory requirements.
• Confer with other departments to coordinate product development and/or improvement;
• Communicate data, statistical, and/or programming issues with internal and external (client/sponsor) programmers, statisticians, and clinical team members;
• Present statistical and non-statistical results using charts, bullets, and graphs in meeting or conference to internal team members, clients, and sponsors.
:
· M.S. in Applied Statistics, Biostatistics, Mathematics, Computer Science, or other related fields
· Have knowledge of pharmaceutical industry data standards such as CDISC SDTM and ADaM and produce the SDTM and analysis datasets to meet these data standards.
· Have understanding of regulatory, industry, and technology standards and requirements and follow the standards and requirements to produce assigned deliverables.
· Ability to work in a team environment
· High proficiency in Microsoft Office, PowerPoint, and Excel Spreadsheet,
· Excellent oral and written communication skills;
· Strong ability in handling multi-tasks within set time frame;
· Strong ability in identifying complex problems, evaluating options, and implementing solutions.
Job Type: Full-time
Pay: $66,034.66 - $74,525.61 per year
Experience:
• working with a CRO: 2 years (Required)
• pharmaceutical: 2 years (Required)
Ability to Commute:
• Somerset, NJ 08873 (Required)
Work Location: Hybrid remote in Somerset, NJ 08873
Location: New Jersey
Posted: Aug. 14, 2024, 2:44 a.m.
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