Title: Statistical Programmer / SAS Programmer / Clinical Programmer
Location: Berkeley Heights, NJ
Duration: 6 month contract with extensions/renewals.
About the Company:
A Global Pharma company headquartered on the East Coast are seeking a Clinical Programmer with experience in and knowledge of SAS Programming. The CDM will work with ongoing clinical studies within varied therapeutic areas.
This position provides end-to-end programming support throughout multiple phases of clinical studies. Knowledge of SAS is essential.
Your Main Responsibilities:
- Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.
- Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
- Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
- Ensure consistency and adherence to standards within their therapeutic area.
- Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
- Oversee the services provided by CROs.
- Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros.
- Provide training on departmental SOPs/WPs and standard programs.
- Contribute to the creation of naming conventions and standards for the programming environment.
- Participate in industry wide technical discussions.
- Bachelor's degree in life science, statistics, mathematics, computer science, or related field is required; Master's degree is preferred.
- 8 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with a Bachelor's degree; or 5 plus years' experience with a MS/MA degree.
- Experience in Immunology, Inflammation, Oncology, Hematology Cancer (i.e. CLL) and Medical Affair Projects are preferred.
- Demonstrated proficiency in using SAS to produce derived analysis datasets and produce TFLs.
- Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.
- Demonstrated skills in using additional software tools and applications (e.g. MS office, XML).
- Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
- Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
- In-depth understanding of regulatory, industry, and technology standards and requirements.
- Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
- Demonstrated ability to work in a team environment with clinical team members.
Why work here?
This is an excellent opportunity to join a fast-paced, hardworking team at a Biotech & Pharma leader on the Fortune 500 list. With over a 90% CEO approval rate and an 80% recommendation rate on Glassdoor, this company is the ideal environment to build your career and excel as a Clinical programmer.
Sthree US is acting as an Employment Business in relation to this vacancy.