Statistical Programmer, BDS

About Certara 
Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.

Certara Integrated Drug Development is the largest pharmacometrics consulting organization in the world. Biometrics Data Sciences (IDD – BDS) is made up of statisticians and statistical programmers. Biostatistics is a relatively new service group at Certara, which provides the successful candidate the opportunity to help build a team from the ground up. This enables us to assure that various career pathways are offered to match the ambition and personal interests of our employees!

As one of Certara’s teams, we deliver value by providing high quality datasets, accurate analyses, and first-rate reporting to strengthen global regulatory submissions. Our current employees have deep experience in drug development in multiple therapeutic areas and bring a track record of success and a broad range of expertise to our growing department.

As Statistical Programming Consultant, you will use your SAS 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. The analysis datasets will be based on source clinical data provided by our client companies; mostly in the form of SAS datasets, but occasionally also as excel/csv files.

In addition, you will conduct quality control and quality assurance activities on datasets and outputs and may participate in company initiatives to improve efficiency of data management, analysis, and reporting (IT, methodology, automation, quality).

You will work closely in teams lead by statistical programmers, statisticians, and drug development consultants supporting a variety of client projects (therapeutic areas, data types).

• Sc., M.Sc., or equivalent education in Biostatistics/Statistics,
• Bioinformatics, Life Sciences, Mathematics, Physical Sciences, or related fields.
• Clinical trials related work experience (6 years for M.Sc., 8 years for B.Sc.) in SAS programming, analysis and reporting in the context of drug development projects.
• Well experienced in Pinnacle21 validation process.
• 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.
• Accuracy and sense of urgency and quality, timely delivery.
• Ability to work on multiple collaborative projects, team player mentality.
• SAS certification is a plus.
• Experience with the R software platform (in addition to SAS) is a plus.