Posted:1 day ago|
Platform:
Work from Office
Full Time
At Emerald Clinical Trials, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region
We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to post-marketing Our therapeutic expertise spans renal, cardiometabolic, and oncologyareas where we make a significant impact on improving global health At the heart of our success is our ability to combine global reach with local knowledge
Our on-the-ground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment By prioritizing people, we deliver better engagement, more accurate data, and faster resultsbringing therapies to patients in need About the Role The Senior Statistical Programmer will support Clinical projects by performing statistical programming as directed by either senior management or Clinical Statistician, take lead programmer role and mentor junior statistical programmers
Your Responsibilities
Perform, plan co-ordinate and implement the following for complex studies: Review statistical analysis plans and mock shells The programming, testing, and documentation of statistical programmes for use in creating statistical tables, figures and listings The programming and specifications writing of SDTM datasets The programming and specifications writing of analysis datasets (derived datasets including efficacy datasets) and transfer files for internal and external clients o Create meta-data representations of regulatory-specific and analysis data sets Conduct peer-review of outputs from junior statistical programmers The programming quality control checks for the source data and report the data issues periodically o Randomisation list generation Provide advanced technical expertise in conjunction with internal and external clients and independently bring project solutions to SP teams and Statistical Programming department, for complex studies
Fulfil project responsibilities at the level of technical team lead for single complex studies or group of studies Directly communicate with internal team including data management, project management, and client statisticians and client team members to ensure appropriate understanding of requirements and project timelines Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables
Participating in RFPs and bid defense meetings Use and promote the use of established standards, SOP and best practice Training, Quality and Compliance Senior Statistical_Programmer_ Complete mandatory training for this role within specified timelines Attend mandatory training sessions required for this role Identify resources and training to support learning and development within this role Comply with all applicable regulations, guidelines, SOPs and project-specific requirements Comply with all designated systems relevant to this role Ensure own quality control of all relevant processes and activities performed Report and escalate identified risks and issues in areas of responsibility according to Clinical and/or project requirement About You Minimum BS degree in sciences related field Minimum 6 years experience with statistical programming in SAS Minimum 6 years experience in the CRO environment Technological proficiency in SAS Competencies Ability and motivated to learn and develop, including sharing knowledge with others Good teamwork and willing to help other team members Technological proficiency including Microsoft Office packages Ability to see the big picture, yet still focus on detail and quality of work Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments
Emerald Clinical
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