Sr. Statistical Programmer job at SimulStat Inc. Summit, NJ, US

Job Description

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.

Requirements:

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.

Job Tags

Similar Jobs

Cummins

Electrician - Hiring Now Job at Cummins

...Job Description We are looking for a talented Electrician - Level II to join our team specializing in Manufacturing for our Cummins Inc. facility in Lakewood, NY. In this role, you will make an impact in the following ways: ~\n Ensure Equipment Availability...

North Bay Children

Preschool Teacher Job at North Bay Children

Job Description Job Description ~ Minimumqualifications: ~15 #ECE Units Needed/Required ~6 ( Included in 15) #Units in Toddler Development~ Applicants must remain in college until they have a total 24 ECE units & 16 Ge units~ CTC Teacher Permit ~ Teachers...

UW Health

Medical Assistant, Peds Specialties Job at UW Health

...Work Schedule: 100% FTE, Day shift. Hours will be Monday-Friday, 8:00 am to 4:30... ...Rockford, IL. We are currently seeking a Medical Assistant (RMA, AAMA, CCMA or NCCT) to:... ...compensation may include: Evening, night, and weekend shift differential Overtime...

Britt Medical Search

Physician Internal Medicine - Competitive Salary Job at Britt Medical Search

...Job Description Seeking BE/BC Internal Medicine Physician achieve patient care objectives and to provide continuity of care for patients... ..., Kidney Care, Mental Health, Ophthalmology, Orthopedics, and Sports Medicine, OT/PT/SLP, Pain Medicine, Pulmonology, Psychiatry (...

KOHLER

Copywriter II Job at KOHLER

...Kohler, WI Opportunity Kohler Co.s award-winning Global Creative team is seeking a digitally focused, concept-driven Copywriter... ...brainstorm content strategy. Support larger digital team on general writing needs where suitable as determined by team lead (projects may...