Senior Specialist Programming

Location: Gaithersburg, MD
Date Posted: 03-28-2018

• Collaborate 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. 
• Collaborate with the Programming Leader to provide programming support to deliver technical programming and information components of a project, including but not limited to: 
o Regulatory response to agency queries 
o Development Safety Update Reports (DSUR) 
o Periodic Benefit-Risk Evaluation Report (PBRER) 
o Investigators brochures (IB) 
o Data submission strategy, i.e., legacy data, pooling data, communications with regulatory agencies 
o Outcomes studies 
o Pharmacokinetics/pharmacodynamics data preparation and analysis 
o Manipulating and analyzing adjudicated data 
o Delivering Clinical Trial Transparency (data de- identification) 
o Data preparation and analysis for Global Medical Affairs work 
• 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 
• Identify opportunities to improve the methodology and provide practical solutions for problems 
• Contribute to the development of best practice to improve quality, efficiency and effectiveness 

Candidate Knowledge, Skills & Experience – Review the standard role profile and capture any additional critical knowledge, skill and experience demands relative to this specific role (e.g. if Programme Manager for SAP consider previous experience of executing SAP projects) 
Add references to specific leadership, core or professional capabilities which will be recruited against and integral to the job. 
• Values: 
o Contributes to innovating and streamlining workflows 
o Knowledgeable of the drug indications within a therapeutic area and data submission standards within that therapeutic area. 
o Contributes to assessing and mitigating risk within a protocol or drug project and proactively determining the need and/or level of escalation 
• BSc in Mathematical, Statistical, Computer Science or Life Science 
• Extensive SAS programming experience 
• Knowledge of database set-up and report publishing requirements 
• Knowledge of technical and regulatory requirements related to the role 
• Knowledge of CDSIC standard and industry best pactices 
• Experience in clinical drug development or healthcare 
• Excellent verbal and written communication skills 
• Assist in developing and delivering training 
Job Dimensions – Review the standard role profile and capture the specific resource management accountabilities required in the role – $ &/or People; key relationship. 
• Leadership role able to lead and direct elements of project work 
• Accountable for the quality of elements of project programming work 
• Accountable for good Information Practice 
• Reports to Programming Team Leader 

Other – Capture any additional information you believe would benefit the candidate. E.g. Motivational Fit – what do they need to enjoy doing to be successful in the role such as attention to detail. 
• Behaviours: 
o 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. Be proactive Excellent collaboration required – needs the energy to work across global & functional boundaries 
o Decision making: constructively challenge others and be receptive to challenge in bringing clarity and robustness (evidence based) to decision making within the team 
o Issue resolution: work collaboratively with the project team to resolve issues, irrespective of whether or not the issues are functional in nature 
o Communication: agree on how to communicate decisions, successes and escalation of issues etc – speak with one voice instead of separate roles. 
• Collaboration required 
• Ability to apply programming expertise to problems, problem solving and quality focus. 
• Other programming languages e.g. S-PLUS, R, XML etc. 
• Familiarity with Open CDISC Validator
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