Principal Statistical Programmer - FSP and Remote

IQVIA • Durham, NC

6d • Remote

About The Position

Purpose: Join our FSP team today! In this role you will 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 Home Based Min 7+ years of CRO/Pharma Industry Therapeutic Areas: Oncology // Immunology // IDV // EDCP Key Skills: Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician. Must have excellent knowledge of CDISC standards (SDTM and ADaM) Thorough understanding of relational database components and theory. Excellent application development skills. Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results. Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes. Minimum of 7+ years of experience in Statistical Programming in pharmaceutical or medical devices industry Good verbal and written communication skills. Ability to work on multiple projects, plan, organize and prioritize activities. Required Knowledge, Skills and Abilities: Experience as technical team lead directly engaging clients and coordinating tasks within a programming team In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Knowledge of statistics, programming and/or clinical drug development process Advanced knowledge of R programming Base SAS, SAS/STAT, SAS Graph and SAS Macro Language Should have experience with SDTM Implementation and ADaM implementation according to CDISC Standards. 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 Ability to independently manage multiple tasks and projects Ability to delegate work to other members of the SP team Excellent accuracy and attention to detail Ability to delegate work to other members of the SP team [SPM] Exhibits routine and occasionally complex problem-solving skills Ability to lead teams and projects and capable of managing at a group level Recognizes when negotiating skills are needed and seeks assistance. Ability to establish and maintain effective working relationships with co-workers, managers and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

Requirements

• Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician.
• Must have excellent knowledge of CDISC standards (SDTM and ADaM)
• Thorough understanding of relational database components and theory.
• Excellent application development skills.
• Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results.
• Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes.
• Minimum of 7+ years of experience in Statistical Programming in pharmaceutical or medical devices industry
• Good verbal and written communication skills.
• Ability to work on multiple projects, plan, organize and prioritize activities.
• Experience as technical team lead directly engaging clients and coordinating tasks within a programming team
• In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Knowledge of statistics, programming and/or clinical drug development process
• Advanced knowledge of R programming Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
• Should have experience with SDTM Implementation and ADaM implementation according to CDISC Standards.
• 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
• Ability to independently manage multiple tasks and projects
• Ability to delegate work to other members of the SP team
• Excellent accuracy and attention to detail
• Ability to delegate work to other members of the SP team [SPM]
• Exhibits routine and occasionally complex problem-solving skills
• Ability to lead teams and projects and capable of managing at a group level
• Recognizes when negotiating skills are needed and seeks assistance.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.

Responsibilities

• 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.
• Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies.
• 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.
• Fulfil project responsibilities at the level of technical team lead for single complex studies or group of studies.
• Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines.
• Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees