Job Description

Overview:
Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries. Responsibilities:
As a Statistical Programming Consultant, you will use your SAS and R programming skills to prepare SDTM and ADaM datasets, Tables, Listings, & Figures (TLFs), as well as create related documents such as aCRF, programming specifications, and define packages (including reviewer's guides) for Phase 1 to Phase 4 clinical trials. Advanced SAS macro programming experience is required for the development of global tools that will increase the efficiency and capacity of the Statistical Programming group. Preclinical SEND dataset preparation is a plus. Experience with NDA/IND-type regulatory submissions is preferred.
In addition, you will conduct quality control and quality assurance activities on datasets and outputs and may participate in company initiatives to improve the efficiency of end-to-end statistical programming activities, analysis, and reporting (IT, methodology, automation, quality). You will work closely in teams led by statistical programmers, statisticians, and drug development consultants, supporting a variety of client projects across various therapeutic areas and complexities. Qualifications:

• B.Sc., M.Sc., or equivalent education in Biostatistics/Statistics, Bioinformatics, Life Sciences, Mathematics, Physical Sciences, or related fields.
• At least 6 years of Clinical trials related work experience in SAS programming, analysis and reporting in the context of drug development projects is required.
• Well experienced in Pinnacle21 validation process, generating define xml using Pinnacle 21.
• Extensive experience in implementing CDISC standards, as well as annotating CRFs, creating specifications for SDTM and ADaM datasets.
• Experienced in creating Define.xml and the corresponding Reviewers' Guide for SDTM and ADaM datasets.
• Good verbal and written communications skills in English.
• Demonstrated knowledge of clinical drug development.
• Proficiency in conducting advanced statistical analyses.
• Must be independent, attention to detail, accountable to quality and timely delivery.
• Ability to work on multiple collaborative projects, team player mentality.
• Experience with the R software platform (in addition to SAS) is a plus.

Certara bases all employment-related decisions on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristics protected by law.

Skills Required