Act as Statistical Programming Project Manager or Project Director for large global or other major programs which may include global responsibilities.
Provide ongoing supervision of projects, advice and consultation to the Lead Programmers and the rest of the programming team to ensure timely and efficient completion of projects. Ensure all issues raised are addressed and all potential issues are handled proactively.
Demonstrate excellent problem solving skills, a proactive approach and the ability to make sound decisions on a regular basis and communicate these clearly.
Interact with the management and wider team in related disciplines e.g. Clinical Data Management, Clinical and Biostatistics, to ensure consistency in approach, ongoing cooperation and teamwork and regular discussion regarding process improvements.
Act as Subject Matter Expert with Partnership Clients
Provide statistical programming input into other disciplines' activities and participate in interdepartmental processes.
Ensure appropriate review of deliverables, implementing follow-up activities at the individual or departmental level.
If desired, may continue to supervise less-experienced statistical programmers carrying out line management responsibilities while maintaining strong technical involvement in projects. This would include Performance Management and Development activities, disciplinary procedures and administrative activities.
Display a positive attitude at all times, promoting and contributing to a good team spirit with a productive and professional environment.
Facilitate the flow of information, comment and feedback between senior management and all levels of staff
Provide training and development of less experienced staff within the department.
Provide training on Statistical Programming related topics to other disciplines.
Ensure good communication across the global management team.
Advise on all aspects of technical planning for projects.
Identify and assist others in identifying changes in scope of projects and provide time and cost modifications and detailed information for the development of change orders.
Provide and interpret resource requirements on a regular basis to ensure that programmers within the department are utilized as fully and as efficiently as possible.
Ensure all Statistical Programming activities are carried out in accordance with Covance or project specific processes.
Ensure the quality work of the group and department through ongoing quality management and review to ensure high quality deliverables to clients and internal customers.
Devise recruitment strategies to maximize ability to find and recruit high caliber staff Perform interview and selection.
Provide input and review of new business proposals, including time and cost estimates and associated documentation; participate in associated client development activities.
Represent Statistical Programming department during audits, particularly those related to new client opportunities.
Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP.
Perform other duties as requested by management.
A minimum of 10 years experience in provision of programming support for clinical trial management and reporting, preferably with at least 2 years of statistical programming responsibility with a CRO.
Strong project management skills and supervisory skills gained from at least 3 years leading large scale projects.
Extensive experience and proven skills in the use of SAS within a clinical trials environment including all processes / practices used within a Statistical Programming environment.
Substantial knowledge of all aspects of clinical trials from initial study set-up to study completion. Complete knowledge and understanding of the processes and procedures used within a Statistical Programming environment and the ability to communicate to programmers and non-programmers alike.
Full understanding of the job roles in programming, to be able to identify training and development needs, opportunities for optimizing staff utilization and employing the most efficient practices.
An excellent understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management.
Ability to apply extensive technical expertise and full knowledge of other related disciplines to provide consultancy and advice on programming and wider related issues to other departments and disciplines.
Excellent organizational skills and the ability to delegate and prioritize work.
Self motivation and the ability to work independently, excellent time management skills and the ability to work to tight deadlines whilst maintaining the highest standards of work.
Good interpersonal skills and the ability to communicate appropriately with all levels of staff throughout the global 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 whilst 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.
A co-operative and team orientated approach.
Project management skills and team leadership experience, as demonstrated by ability to organize and motivate project teams.
Good interview skills to ensure successful recruitment of high caliber candidates.
Good logistical skills in order to manage the work of a team / group of Statistical Programmers.
Good general business awareness and an understanding of the business needs of a CRO.