Principal Stats Programmer (VAX)

Overview

Principal Statistical Programmer within the Hyderabad Hub, delivering biostatistics and programming activities across the Vaccines R&D value chain (Pre-Clinical, Clinical, Translational, CMC) with the Vaccines Global Biostatistical Sciences team.

What you'll do

• Plan and execute high quality and timely statistical programming deliverables in the context of a vaccine project.
• Review and provide feedback on study documents (protocol statistical section, Case Report Form, Statistical Analysis Plan (SAP)) and create mock TLFs.
• Write and provide the programming specifications for the SDTM/ADaM/TLFs to fulfil the study or project objectives.
• Deliver compliant CDISC data packages with all relevant documentation (aCRF, reviewers guide, define.xml) fulfilling Health Authorities expectations.
• Review and provide feedback on integrated analysis plans and create mock TLFs at project level.
• Create the core integrated clinical database, pooling SDTM/ADaM across several studies for reporting purposes such as ISS/ISE/ISI, DSUR, PBRER or safety surveillance.
• Ensure TLF formats fulfil the requirements of targeted publishing (clinical study report, publication, transparency such as EudraCT, CTT.gov, lay summaries).
• Take leadership, guiding more junior staff and ensuring quality and timely deliveries.
• Perform quality control for statistical programming deliverables and complete the associated documentation: validation plan and quality control (QC) documentation.
• Propose and program exploratory and/or post hoc analyses based on problem statement.
• Ensure compliance to SOPs, standards, and guidelines.

What you'll need

• 8+ years of experience in statistical programming for clinical research.
• Some vaccines experience (designs, endpoints, statistical methods).
• SAS (more than 3 years): excellent technical skills in BASE, STAT, MACRO, GRAPH, SQL; familiarity with R and statistical programming.
• Experience programming CDISC SDTM/ADaM datasets, including vaccine specifics (writing specifications, P21, controlled terminology, value-level metadata, analysis results metadata, define.xml, Reviewers Guide).
• Experience providing solutions for complex programming issues, including creation of complex macros, presenting alternatives and identifying the best solution.
• Experience pooling data from multiple studies according to existing specifications.
• Experience planning and drafting specifications for pooling data from multiple studies.
• Consistent successful experience as a lead on several concurrent studies/projects.
• Good understanding of processes associated with clinical trials.
• Ability to independently create specifications.
• Knowledge of descriptive statistics.
• Interpersonal skills necessary for effective teamwork.
• Ability to organize multiple work assignments and establish priorities.
• Critical thinking skills beyond simply following directions or specifications.
• Ability to lead complex and large tasks, with strong project management skills.
• Bachelor's or Master's degree in Statistics, Mathematics, Computer Science or related health sciences, or equivalent experience.
• English: highly effective communication, both oral and written.

Nice to have

• e-submission preparation experience.

Details

• Location: Hyderabad Hub.