Principal Stats Programmer (vax) (Telangana)

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 cutting-edge 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 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 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 SOP s standards and guidelines About you You are a passionate leader with following experience and competences who like the challenge and growing into a new environment Experience 6 years experience in statistical programming clinical research with some Vaccines experience designs endpoints statistical methods SAS 3 years excellent technical skills in BASE STAT MACRO GRAPH SQL R and familiar in statistical programming Experience 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 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 e-submission preparation experience strongly preferred Skills Good understanding of processes associated with clinical trials Ability to independently create specifications Knowledge of descriptive statistics Demonstrate interpersonal skills necessary for effective teamwork Demonstrate ability to organize multiple work assignments and establish priorities Demonstrate critical thinking skills beyond simply following directions or specifications Ability to lead complex and large tasks demonstration of strong project management skills Education Bachelors or Masters degree in Statistics Mathematics Computer Science or related health sciences or equivalent experience null 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 cutting-edge 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 complian