• Poland

Job Description:

Candidate Focus & Challenge

As a member of TA Programming or Standards & Business Solutions, collaborates with the Programming Leader to provide programming support to deliver technical programming and information components of a project, including but not limited to the following Data submission strategy (eg, managing legacy data, pooling data)
Responses to regulatory agency queries
Tables Figures and Listings (TFLs)
Development Safety Update Reports (DSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Investigators brochures (IBs)
Office of Scientific Investigations (OSI) data sets and listings
Regulatory and/or Payer submission related analysis data sets and/or TFLs
Associated quality and process documentation as per applicable business processes

Collaborates with the Programming Leader to provide programming support to deliver technical programming and information components of a study, including but not limited to the following Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets
Tables Figures and Listings (TFLs)
Pharmacokinetics/pharmacodynamics data preparation and analysis
Manipulating and analyzing adjudicated data
Data preparation and analysis for Global Medical Affairs work
Clinical Trial Transparency deliverables (data de-identification, results posting files)

Collaborates with the Programming Leader to provide support for aspects of the clinical development process, including clinical development plans, regulatory submissions, commercialisation and scientific utilisation data for AZ products
Produce and maintain the technical database standards and Programming Specification documents
Contribute to the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM and RDB databases by these partners
Provide support to the regulatory submissions including specification and delivery of overview databases, outputs and response to regulatory questions
Contributes to the development of best practice to improve quality, efficiency and effectiveness

Candidate Knowledge, Skills & Experience

BSc in mathematics, statistics, engineering, computer science, or life or social sciences
Extensive SAS programming knowledge and experience
Knowledge of database set-up and report publishing requirements
Knowledge of technical and regulatory requirements related to the role
Knowledge of CDSIC standard (eg, CDASH, SDTM, ADaM) and industry best practices
Knowledge and experience of clinical drug development or healthcare
Excellent verbal and written communication skills
Assist in developing and delivering training
Able to demonstrate team working and role leadership skills appropriate to level

Job Dimensions

Lead the quality of own programming work and aspects of the teams as well as the completeness of applicable quality and process documentation
Accountable for good Information Practice on all assigned activities
When deployed to a B&I drug project team, operates under the leadership, direction and oversight of a Global Project Programmer (GPP) or her/his delegate

Other Qualifications & Capabilities

Advanced verbal and written communication and collaboration skills
Competent to advanced problem solving and conflict resolution
Needs the energy to work across global & functional boundaries
Travel willingness and ability to travel domestically and/or internationally
Ability to apply programming knowledge and skills to problems, problem solving, and quality focus
Contributes to defining business processes and accurately completes and manages associated documentation
Team commitment prioritise attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team
Diligence attention to detail and ability to manage concurrent projects and activities within those projects

Senior Programmer

Clinical Development

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : IT Software : Software Products & Services
Role : Software Engineer
Salary : As per Industry Standards
Deadline : 19th Feb 2020

Key Skills:

Company Profile:


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