Principal Statistical Programmer - Clinical Vaccine Research (Hyderabad)

Principal Stats Programmer (VAX) External Job Description As a Principal Statistical Programmer within our Hyderabad Hub, youll 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 creative 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 project At 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 TLFs Write and provide the programming specifications for the SDTM/ADaM/TLFs to fulfil the study or project objectives Deliver compliant CDISC data package with all relevant documentation (ie: aCRF, reviewers guide, define.xml) fulfilling Heath Authorities expectations At project level for various analyses within an asset: Review and provide feedback on integrated analysis plan and create mock TLFs Create core integrated clinical database, pooling SDTM/ADaM across several studies for different reporting purposes like ISS/ISE/ISI, DSUR, PBRER or safety surveillance Ensure TLFs 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 deliveries Perform quality control for statistical programming deliverab. Principal Stats Programmer (VAX) External Job Description As a Principal Statistical Programmer within our Hyderabad Hub, youll 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 creative 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 project At 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 TLFs Write and provide the programming specifications for the SDTM/ADaM/TLFs to fulfil the study or project objectives Deliver compliant CDISC data package with all relevant documentation (ie: aCRF, reviewers guide, define.xml) fulfilling Heath Authorities expectations At project level for various analyses within an asset: Review and provide feedback on integrated analysis plan and create mock TLFs Create core integrated clinical database, pooling SDTM/ADaM across several studies for different reporting purposes like ISS/ISE/ISI, DSUR, PBRER or safety surveillance Ensure TLFs 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 deliveries Perform quality control for statistical programming deliverab.