Sr. Statistical Programmer -remote
This position will work closely with the Director of Statistical Programming and other members of the Biometrics team to provide programming support across specific programs. The ideal candidate will provide hands-on programming and validation support to project teams Essential Responsibilities:
- Program analysis datasets, statistical tables, figures, and listings.
- Generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation.
- Provide statistical programming and validation support for clinical study reports and help coordinate programming activities with Biometrics lead and other study programmers to meet timelines.
- Ensure quality of project programming deliverables.
- Provide input on programming methodologies to support the clinical development process.
- Minimum of Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related technical discipline.
- Minimum of 4 years’ experience in clinical research, ideally as a SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment.
- Technical knowledge and experience with SDTM, ADaM, and Define.XML.
- Clear understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP).
- Strong knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) and experience with MS Office are required. Familiarity or experience with R Software is a plus.
- Proven experience with UNIX and Windows operating systems.
- Ability to effectively communicate and perform in a high demand and dynamic working environment.
Recommended Jobs
Clinical Manager
Job Description Job Description Benefits: Bonus based on performance Company parties Opportunity for advancement Profit sharing Training & development Competitive salary Flex…
AgencyHub.com - Work From Home
Are you overwhelmingly positive? Do you consider yourself a creative problem solver? Are you proactive and know how to grab opportunities? If yes... then THIS ... is the 6-FIGURE opportunity you'…
ENT Needed - Opportunity for Leadership Position if Desired
Brown University Health (BUH) has an opportunity for a board certified or eligible ENT to join our team based in Fall River, MA. BUH Otolaryngology is a program of Rhode Island Hospital, an affiliate…
Cleaning Team Member
PROVIDE FOR YOU: * Full time hours (averaging 30-40 hours per week) with benefits * Free hand-on field training provided to you * Daily schedule with no nights and no weekend work! * FREE unifo…
Senior Software Engineer, Next Gen Compute
Job Description Job Description Motional's global headquarters are located at 100 Northern Avenue in Boston, MA. Nestled in the bustling Seaport district with sweeping views of Boston Harbor and …
Maintenance Planner
Job Description Job Description Company Description With more than 100 years of experience, Sika is a worldwide innovation and sustainability leader in the development and production of syst…
Build Infrastructure Engineer
We're redefining how robots are deployed. Our platform enables users to simulate, test, and optimize entire robotic systems in parallel. By removing the barriers that have kept advanced robotics out …
Legal Billing Coordinator
Job Details: Legal Billing Coordinator 65-85K, Hybrid. Liberty Personnel is partnered with a TOP 50 AM Law Firm seeking an experienced Legal Billing Coordinator to join their team. Respons…
Assistant Professor - Sustainable Food: Aquaculture
Job Description The School for the Environment (SFE) at the University of Massachusetts Boston is seeking candidates for a full-time tenure-track Assistant Professor position in Sustainable Food: Aq…
Heavy Equipment Operator
Job Description Job Description Job Title: Heavy Equipment Operator Company: Waste Options Nantucket LLC Location: Nantucket, NY Job Type: Full-Time Compensation: Competitive, ba…