Statistical Programmer Lead

2 days ago

Hyderabad, Telangana, India IQVIA Full time

Job Overview
As a Senior Statistical Programmer at IQVIA, you will be responsible for developing statistical methods sections of protocols and reviewing case report forms (CRFs). You will prepare analysis plans and write specifications for analysis files, tables, and figures. Additionally, you will communicate with clients regarding study protocol or statistical analysis issues as they arise. You will also communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Your responsibilities will include interpreting analyses and writing statistical sections of study reports. Furthermore, you will be accountable for controlling costs and maximizing revenue recognition. You will provide training, guidance, and mentorship to lower-level and new staff.

Key Responsibilities
• Producing high-quality deliverables, including completing and reviewing complex tasks with a focus on accuracy. You will conduct all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken. You will check programming logs for cleanliness and correct processing of data. You will input into the Data Issues log and follow issues to appropriate resolution.
• Leadership: Performing statistical team lead role on single studies. You will work closely with the Project Team Lead and supervisor to deliver on time, with high quality, and within budget. You will build and maintain effective customer relationships, driving statistical discussions, providing support and/or guidance for statistical activities. You will demonstrate and promote efficient communication. If in the lead role, you will run meetings, documenting where necessary, and following up on actions. You will actively participate in internal project team meetings, providing timely progress updates. As a lead, you will have input on estimate at completion (EAC) reporting.
• Data Management: Assisting in reviewing or advising data management staff on database design, validation checks, and critical data. You will handle data issue resolutions. If in the lead biostatistical role, you will handle the lock and unblinding process with appropriate supervision.
• Statistical Analysis Plan (SAP) and Shells: Authoring or performing quality control review (QC) of SAPs and shells. You will make best use of resources and expertise within the organization (e.g. Libraries, templates, and consultants for complex statistical methods). You may author or QC complex SAPs, under supervision if needed.
• Datasets: Writing and maintaining programming specifications. You will program assigned datasets to industry standards. You will handle dataset derivations and assignment.
• Tables, Listings, and Figures (TLFs): Writing programming specifications for statistical analysis outputs. You will program TLFs, maximizing programming efficiency with the use of tools, where applicable. You will check resulting output for format and content, and question specifications as needed. You will ensure consistency across items produced.
• Timelines: Planning and documenting timelines, forecasting resource needs, suggesting work may be out of scope.
• Financials: Sharing accountability (with resource managers) for the financial success of assigned studies. You will be accountable for controlling costs and maximizing revenue recognition. You will be responsible for sharing budget expectations with the team. You will raise concerns to manager if new work or rework appears to be out of scope. You will understand 'scope of work' and have an awareness of contract and budget assumptions.
• Knowledge Sharing: Helping train staff regarding operational items. You will mentor junior staff. You will support colleagues and provide motivation as needed.
• Risk Management: Identifying risks to project delivery and/or quality and spending time to proactively avoid as well as proposing solutions to mitigate risks. Where possible, you will anticipate risks to minimize the need for study-level escalations.
• Other Clinical Data Interchange Standards Consortium (CDISC) requirements: Leadership: Under supervision within Compound. You may perform statistical team lead role on studies within a compound. In addition to leadership responsibilities above, you will prioritize and take a proactive approach to gain efficiencies in work across protocols.
• Study Start-up: Assisting with protocol development, sample size calculation, protocol, and case report form (CRF) review.
• Protocol: Authoring or performing quality control (QC) review of the statistical section of a protocol (making best use of resources and expertise within the organization (e.g. Libraries, templates, and consultants for complex statistical methods).
• Proposals: May be able to review and comment on proposals/budgets at a study level. May contribute to request for proposals (RFP). May be expected to present at bid defenses.
• Clinical Study Report (CSR): Reviews or drafts CSR or statistical report.
• Customer: On occasion, may serve as primary point of contact for customer. May also consult on operational topics with clients.
• Lock and Unblinding Process: Handling the database lock and unblinding process. May participate on the biostatistics randomization team (drafts randomization specifications and/or reduces or performs quality control (QC) review of randomization schedules). May serve as unblinded lead statistician.
• Other Responsibilities: As defined on an ad-hoc basis by managers. May assist with cross-functional collaboration.

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