Principal Statistical Programmer

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Remote Job

Mid-Senior level

Posted 4 months ago
Job details

As a Principal Statistical Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.


Responsibilities:

  • Independently develop accurate and CDISC compliant ADaM specifications.
  • Independently develop/validate programs that generate analysis datasets based on ADaM specifications.
  • Independently develop/validate programs that generate tables and listings specified in the protocol or the Statistical Analysis Plan (SAP).
  • Good understanding of regulatory requirements. Prepare XPTs Define.xml, Reviewer’s Guide and analysis metadata report, executable programs for CRT packages.
  • Run P21 checks and resolve the P21 validation report related error and document details.
  • Perform quality control on final reports. Generate the adhoc and custom reports as requested.
  • Provide QC and validation reports and document corresponding details.
  • Communicate with programming and statistics leads, data managers and other team members.
  • Provide project progress updates of programming activities.


Qualifications:

  • BS/MS in Statistics, Biostatistics, Computer Science, Mathematics or Life Sciences - 10+ years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry
  • Required Skills Include: - Strong SAS programming skills required in Windows & UNIX environment with proficiency in SAS/Base, SAS Macros, SAS/Stat - Knowledge of working in SAS Grid environment with experience in SAS Enterprise Guide and SAS Studio is a plus
  • Experience with all clinical phases I, II, III and IV of trails is desirable
  • Good understanding of standards specific to clinical trials such as CDISC, SDTM, ADaM, MedDRA, WHODRUG
  • Strong problem-solving skills
  • Good organizational and time management skills.
  • Excellent communication and interpersonal skills and capability of communicating technical concepts
  • Excellent organizational skills, demonstrated success to multi-task and deliver viable solutions in a fast-paced environment with changing priorities.
  • Should have experience in lead role.
  • Experience in submission to regulatory authorities

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Experience:

  • Mid-Senior level

Remote Job:

  • Yes

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 14, 2024
Company Overview
ICON Strategic Solutions
ICON Strategic Solutions

Current Openings: 0

ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services. Through combined functional, operational, and talent expertise, ICON offers FSP models that provide cost-savings, clinical expertise and significantly improve business performance. Follow us for the latest industry insights as well as vacancies and insight into life at ICON.
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