Job Overview :
Act as the Lead Programmer overseeing technical planning for increasingly complex projects including global and multiple study projects, Integrated of Summary of Safety (ISS) and integrated Summary of Efficacy (ISE) and electronic submissions.
If desired, may supervise less-experienced statistical programmers carrying out line management responsibilities. This would include Performance Management and Development activities, disciplinary procedures and administrative activities.
Act as the Biometrics Project Manager for assigned projects.
Work on complex problems where analysis of situations or data requires an evaluation of intangible variables; development of technical solutions to abstract problems which require the use of ingenuity and creativity.
Review and interpret Statistical Analysis Plans and provide comments for assigned projects.
Ensure quality of personal work and the work of the programming team when acting as a Biometrics Project Manager and Lead Programmer meeting completions dates with minimal supervision.
Representing Statistical Programming at internal project team meetings, client meetings and audits.
Contribute to proposal activities and client presentations providing time and cost estimates for statistical programming activities.
Perform ongoing review of hours for assigned projects, ensure all issues are highlighted and resolved as quickly as possible and ensure all non-
contract tasks are identified, tracked and included in change order forms.
Provide ongoing supervision, advice and consultation to Lead Programmers and programming team to ensure timely and efficient completion of projects.
Provide feedback to management on the development potential of staff to assist in staff development.
Perform interviews for selection of potential candidates.
Ensure that study documentation is maintained to the standard required according to processes and acceptable for audit.
Provide input into assessments of resource requirements on regular basis. Provide feedback to management if any action is needed to increase utilization, improve efficiency or amend the resource levels required on a project.
Encourage and participate in the ongoing review of the processes used by the statistical Programming group to ensure processes are continually improved.
Carry out all activities according to Covance SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP).
Ensure adherence to programming guidelines.
Perform other duties as assigned by senior Statistical Programming staff.
Education / Qualifications :
BSc in a computing, life science, mathematical or Statistical subject.
A high computing content is considered beneficial; however proven computing skills are most important.
Alternative academic qualifications or experience are assessed to ensure equivalent background.
8 years experience in provision of programming support for clinical trial management and reporting, or equivalent experience.
Extensive experience and proven skills in the development and review of SAS programs within a clinical trials environment.
Experience in the preparation and review of Statistical Analysis Plans, study set-up and review of study specific documents, e.
g. CRF and data validation guidelines.
Knowledge of all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.
g. Biostatistics and Clinical Data Management.
Thorough knowledge and understanding of the processes and procedures used within a Statistical Programming environment and the ability to communicate to programmers and nonprogrammers alike.
Ability to apply extensive technical expertise and has full knowledge of other related disciplines to provide Consultancy and advice on programming and wider related issues to other departments and disciplines.
Excellent problem solving skills, a proactive approach, anticipating issues and working to ensure they are avoided or resolved as quickly as possible.
Self motivation and ability to work independently without appreciable direction.
A willingness to make decisions, seeking advice from senior Statistical Programming staff to confirm decisions when necessary.
Excellent organizational, time management and project management skills with team leadership experience, as demonstrated by ability to organize and motivate project teams and the ability to delegate and prioritize work to meet project timelines.
Good interpersonal skills and the ability to communicate appropriately with all levels of staff throughout the organization and confidently with other disciplines and external clients.
Ability to promote a good team working environment, providing the client with a high quality service while recognizing our business needs.
A proactive approach to developing and maintaining effective working relationships with staff in other disciplines, often in other locations and in working to achieve consistent processes and standards across them.
Covance is an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.