Senior Statistical Programmer - IQVIA

Job Family Description

Conducts statistical analyses for client reports and publications, performs advanced statistical programming and biostatistical analyses and utilizes findings, and insights for practical application to further business operations comes across innovative findings and discoveries for a solution and product development.

Sub-Family Description

Develops, executes, and reviews programs to provide statistical programming support for statisticians, clients, or business demands to source, organize (creating statistical tables, listings, and graphs) and interpret complex data sets.

Creates programming specifications, program development, program validation, and program output finalization associated with analysis datasets, tables, figures, listings, and regulatory submission data packages; and provides programming support for additional business needs such as safety reporting, patient data reviews, and risk mitigation.

Job Details:

• Position: – Sr. Statistical Programmer 
• Home Based (mostly)
• Min 3+ years of CRO/Pharma Industry 
• Therapeutic Areas: Oncology // Immunology // IDV // EDCP 

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Key Skills:

• Preferred to have R programming
• Must have SAS® Base, and good knowledge of SAS® graph and SAS® Macros. 
• Capable of implementing more advanced statistical procedures as per specifications provided by biostatisticians. 

• 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 4+ years of experience in Statistical Programming in the 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. 

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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 the Statistical Programming department, for complex studies. 
• Fulfill 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. 

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

• Bachelor’s degree from reputable university preferably in science/ mathematics-related fields