IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
To provide advanced technical expertise to develop and maintain programs to meet internal and external clients’ needs. Plan and lead the development of project-related solutions to the full scope of statistical programming tasks. Provide technical expertise to the Statistical Programming department.
- Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to SOPs, for each task undertaken. Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution.;
- Datasets: Writes and maintains programming specifications datasets. Programs assigned datasets to industry standards. Handles dataset derivations and assignment.;
- Tables, Listings and Figures (TLFs): Programs TLFs, maximizes programming efficiency with use of biostatistical tools, where applicable. Checks resulting output for format and content, and questions specification as needed. Ensures consistency across items produced.;
- Leadership: Perform as lead programmer on assigned studies. Through this, works closely with the Biostatistical Team Lead and supervisor, to deliver on time, with high quality and within budget. Tasks include but are not limited to: Develops an efficient programming strategy utilizing available tools and creation/ maintenance of project specific macros, ensures compliance with Good Programming Practice as per SOPs. Demonstrates and promotes efficient communication. If in lead role, runs meetings, documenting where necessary and following up on actions. Actively participates in internal project team meetings, provides timely progress updates. As a lead, will have input on estimate at completion (EAC) reporting.;
- Timelines: Plans and documents timelines, forecasts resource needs, suggests work may be out of scope.;
- Project Programming Set Up: Programming project set up and maintenance of BIOSETUP, global tools & project macros, where applicable. Programming project set up for integrated databases, with supervision.;
- Statistical Analysis Plan (SAP) and Shells: Performs programming review of SAP and shells, where applicable. Writes programming specifications/shells for safety outputs, where applicable.;
- Financials: Shares accountability (with resource managers) for the financial success of their studies. Responsible for sharing budget expectations with their team. Raises concerns to manager if new work or rework appears to be Out of Scope. Understands 'scope of work' and has an awareness of contract and budget assumptions.;
- Knowledge Sharing: Helps train staff regarding operational items. Mentors junior staff.;
- Risk Management: Identifies risks to project delivery and/or quality and spends time to proactively avoid as well as proposes solutions to mitigate risks.; Other CDISC requirements: Reviews Pinnacle 21 output and resolves issues. Creates or performs quality control (QC) review of define.xmls, SDTM and/ or ADaM reviewers guide (SDRG, ADRG), under supervision as needed.;
- Under Supervision; Leadership: Under supervision within Compound. May perform lead programmer role on studies within a compound. In addition to the leadership responsibilities above, also prioritizes and takes proactive approach to gain efficiencies in work across protocols.;
- Proposals: May be able to review and comment on proposals/budgets at a study level. May contribute to request for proposals (RFPs). May be expected to present at bid defenses.;
- Customer: On occasion, may serve as primary point of contact for customer. May also consult on operational topics with clients.;
- Lock and Unblinding Process: May serve as unblinded lead programmer, where applicable.
- Technology: Awareness and utilization of technology offerings (Biostatistical Tools) rolled out by the Global business unit. May be a contributor to development of technology offerings.;
- Other Responsibilities: As defined on ad-hoc basis by managers. May assist with cross functional collaboration.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Experience in Statistical programming in SAS within the CRO/Pharmaceutical/Biotechnology/Healthcare industries
- Experience as project 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
- Deep knowledge of statistics, programming and/or clinical drug development process and advanced knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
- Good organizational, social, leadership and communication skills
- Ability to independently lead multiple tasks and projects and to delegate work to other members of the SP team
- Excellent accuracy and attention to detail
- Exhibit routine and occasionally complex analytical skills
- Recognize when negotiating skills are needed and seeks assistance
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.