Sr. Statistical Programmer Job at SimulStat Inc., Summit, NJ

N01wZEFBbWszUU1rYlRScnBlWml0Skpu
  • SimulStat Inc.
  • Summit, NJ

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

Invictus

Communications Assistant - Entry Level Job at Invictus

 ...are seeking a motivated and enthusiastic Entry-Level Communications Assistant to join our...  ...team, youll gain hands-on experience in event coordination, community relations, and outreach...  .... Key Responsibilities: Assist in planning and executing public-facing events,... 

Vaco Recruiter Services

Hybrid Senior Accountant — GAAP, Nonprofit Job at Vaco Recruiter Services

 ...A mission-driven financial services organization is seeking a Senior Accountant to support financial operations and reporting functions. This hybrid role requires expertise in GAAP and offers a salary range of $100K - $115K. The successful candidate will be responsible... 

Sparrow Italia - New York

Executive Sous Chef Job at Sparrow Italia - New York

 ...Why this role: The Executive Sous Chef is a senior back-of-house leader and the primary operational partner to the Executive Chef. This role is ideal for a highly experienced culinary leader who excels at driving consistency, accountability, and execution at scale.... 

ACS Consultancy Services

Java Developer (WebLogic, HL7, SOA, SAS, REST) Job at ACS Consultancy Services

 ...Job Title: Java Developer (WebLogic, HL7, SOA, SAS, REST) Location : Albany, NY onsite We are currently seeking candidates who meet the following qualification Qualifications : Experience using and administering Oracle WebLogic Application Server... 

Ross Stores

IT Manager II Job at Ross Stores

 ...continuous learning opportunities and development for our teams. GENERAL PURPOSE: Sitting in the New York Buying Office, the IT Manager II leads complex merchandising initiatives, translating business needs into system requirements and delivering end-to-end IT...