Remote Senior Programmer

Location: Gaithersburg, MD
Date Posted: 07-03-2018
Candidate Focus & Challenge –
•             Collaborate with the Programming Leader to provide support for aspects of the clinical development process, including clinical development plans, regulatory submissions, commercialization and scientific utilization data for our 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 –
•             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 –
•             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 –
•             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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