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As a Principal Statistical Programmer within our Hyderabad Hub, you’ll be part of a performing team, delivering biostatistics and programming activities throughout the Vaccines R&D value chain (Pre-Clinical, Clinical, Translational, CMC) with our Vaccines Global Biostatistical Sciences team.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year.
Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities.
We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world
Main responsibilities:
Plan and execute high quality and timely statistical programming deliverables in the context of a vaccine projectAt study level for various analyses within a study:Review and provide feedback on study documents (e.g.: protocol statistical section, Case Report Form, Statistical Analysis Plan (SAP)); create mock TLFsWrite and provide the programming specifications for the SDTM/ADaM/TLFs to fulfil the study or project objectivesDeliver compliant CDISC data package with all relevant documentation (ie: aCRF, reviewers guide, define.xml) fulfilling Heath Authorities expectationsAt project level for various analyses within an asset:Review and provide feedback on integrated analysis plan and create mock TLFsCreate core integrated clinical database, pooling SDTM/ADaM across several studies for different reporting purposes like ISS/ISE/ISI, DSUR, PBRER or safety surveillanceEnsure TLF’s format fulfil the requirements of targeted publishing (i.e.: clinical study report, publication, Transparency like Eudract, CTT.gov, lay summaries,...)Take leadership, guiding more junior staff and ensuring quality and timely deliveriesPerform 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 statementEnsure compliance to SOP's, standards, and guidelines.
You are a passionate leader with following experience and competences who like the challenge and growing into a new environment:
Experience:
Experience in statistical programming clinical research with some Vaccines experience (designs, endpoints, statistical methods, …)SAS : excellent technical skills in BASE, STAT, MACRO, GRAPH, SQL, R, and familiar in statistical programmingExperience programming CDISC SDTM/ADaM datasets and notably vaccines specifics (including writing specifications, P21, proficiency with controlled terminology, value-level metadata, analysis results metadata, define.xml, Reviewers Guide)Experience in providing solutions for complex programming issues (including creation of complex macros), presenting alternatives and identifying the best solutionExperience pooling data from multiple studies according to existing specificationsExperience planning and drafting specifications for pooling data from multiple studiesConsistent successful experience as a lead on several concurrent studies/projectse-submission preparation experience strongly preferredSkills:
Good understanding of processes associated with clinical trialsAbility to independently create specificationsKnowledge of descriptive statisticsDemonstrate interpersonal skills necessary for effective teamworkDemonstrate ability to organize multiple work assignments and establish prioritiesDemonstrate critical thinking skills beyond simply following directions or specificationsAbility to lead complex and large tasks, demonstration of strong project management skillsEducation:
Bachelors or Masters degree in Statistics, Mathematics, Computer Science or related health sciences or equivalent experience
Pursue , discover
Better is out there.
Better medications, better outcomes, better science.
But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
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