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Principal Statistical Programmer Jobs

Company

IQVIA

Address Durham, NC, United States
Employment type FULL_TIME
Salary
Category Pharmaceutical Manufacturing
Expires 2023-06-13
Posted at 11 months ago
Job Description
Location: Homebased anywhere in the US
Purpose:
Experienced R programmers needed to provide technical expertise to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.
Job Details:
  • Position: – Principal Statistical Programmer
  • Therapeutic Areas: Oncology // Immunology // IDV // EDCP
  • Home Based
  • Min 4+ years of CRO/Pharma Industry
Key Skills:
  • Excellent application development skills.
  • Good verbal and written communication skills.
  • Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician.
  • Ability to work on multiple projects, plan, organize and prioritize activities.
  • Thorough understanding of relational database components and theory.
  • Must have excellent knowledge of CDISC standards (SDTM and ADaM)
  • Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes.
  • Minimum of 4+ years of experience in Statistical Programming in pharmaceutical or medical devices industry
  • Must have expertise of R programming as well as SAS® Base, and good knowledge of SAS® graph and SAS® Macros.
  • Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results.
Required Knowledge, Skills and Abilities:
  • Knowledge of statistics, programming and/or clinical drug development process
  • Excellent accuracy and attention to detail
  • Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
  • Ability to lead teams and projects and capable of managing at a group level
  • Must have expertise in SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS/SQL.
  • Good organizational, interpersonal, leadership and communication skills
  • Exhibits routine and occasionally complex problem-solving skills
  • Ability to delegate work to other members of the SP team
  • Experience as technical team lead directly engaging clients and coordinating tasks within a programming team
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients.
  • Recognizes when negotiating skills are needed and seeks assistance.
  • Ability to independently manage multiple tasks and projects
  • Ability to delegate work to other members of the SP team [SPM]
  • In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines 
  • Advanced knowledge of R programming
  • Should have experience with SDTM Implementation and ADaM implementation according to CDISC Standards.
Responsibilities:
  • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies.
  • Perform, plan co-ordinate and implement the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files  for internal and external clients and (iii) the programming  quality control checks for the source data and report the data issues periodically..
  • Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines.
  • Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies.
  • Fulfil project responsibilities at the level of technical team lead for single complex studies or group of studies.
  • Use and promote the use of established standards, SOP and best practices.
  • Provide training and mentoring to SP team members and Statistical Programming department staff.
  • Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
  • Bachelor's degree from reputable university preferably in science/ mathematics related fields
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status