Urgent Search Statistical Programmer Ii

Overview ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence and we welcome you to join us on our mission to shape the future of clinical development Job Title Statistical Programmer II Location Chennai Bangalore Trivandrum Responsibilities What you will be doing Services rendered will adhere to applicable Johnson Johnson SOPs WIs policies local regulatory requirements ICH-GCP etc Creation of ADaM datasets based on current ADaM standards Creation of Tables Listings and Figures following J J specifications Creation of Subject Narratives following J J templates to support Narrative development Creation of other ancillary data streams including but not limited to clinical registry reporting files e g Clintrials gov EudraCT Bioresearch monitoring reports BIMO QC of all programmed output Creation and or maintenance of detailed specification documentation Development and validation of electronic submission packages that comply with submission requirements from FDA EMEA and other regulatory agencies as needed High level experience in the implementation of SAS Base and Macro in the analysis of clinical trial data Working knowledge of clinical trial data Study population safety efficacy PK PD in the therapeutic are being serviced Demonstrated understanding of current industry standards for submission of clinical trial data Qualifications You are Bachelors degree or higher and or equivalent in computer science mathematics or other scientific field or equivalent theoretical technical depth Advanced degree Master s PhD or equivalent preferred for Level 4 Demonstrated written and verbal communication Minimum 4 years of experience What ICON can offer you Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent In addition to your competitive salary ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family Our benefits examples include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme TELUS Health offering 24-hour access to a global network of over 80 000 independent specialised professionals who are there to support you and your familys well-being Life assurance Flexible country-specific optional benefits including childcare vouchers bike purchase schemes discounted gym memberships subsidised travel passes health assessments among others Visit our careers website to read more about the benefits of working at ICON https careers iconplc com benefits At ICON diversity inclusion belonging are fundamental to our culture and values Our rich diversity makes us more innovative which helps us better serve our people patients customers and our communities We re proud of our diverse workforce and the work weve done to become a more inclusive organisation Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability or protected veteran status If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please let us know through the form below https careers iconplc com reasonable-accommodations Interested in the role but unsure if you meet all of the requirements We would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles