Remote Principal Programmer

Location: Gaithersburg, MD
Date Posted: 07-03-2018
Candidate Focus & Challenge –
•             Act as the strategic computer programming leader to provide support for all aspects of the clinical development process including, but not limited to, clinical development plans, regulatory submissions, programming and information deliverables, commercialisation and scientific utilisation data for our products.
•             Lead 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.
•             Oversee the quality of all deliverables, holding partners and providers accountable for the quality of their deliverable.
•             Lead programming support to the regulatory submissions including specification and delivery of overview data bases, output 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             Able to leverage experience to innovate and streamline workflows
o             Knowledgeable of the drug indications within a therapeutic area, their analysis trends, and their effects on data submission standards.
o             Able to effectively assess and mitigate risk within a protocol or drug project and proactively determine the need and/or level of escalation
•             BS in Mathematical, Statistical, Computer Science or Life Science
•             Extensive SAS programming expertise to an advanced level
•             Comprehensive knowledge of technical and regulatory requirements related to the role
•             Knowledge of CDSIC standards and industry best practices
•             Extensive experience in clinical drug development or healthcare
•             Experience in Regulatory submissions
•             Excellent verbal and written communication skills and influence stakeholders
•             Lead the development and delivery of 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 project work
•             Accountable for the quality of elements of project programming work worldwide
•             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.
•             Excellent collaboration required – needs the energy to work across global & functional boundaries
•             Ability to apply programming expertise to problems, problem solving and quality focus.
•             Other programming languages e.g. S-PLUS, R, XML etc.
•             Extensive knowledge of Open CDISC Validator
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