Programming Team Leader

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Basic Purpose and Objective:

Lead position contributing to functions of the programming roles within the Biostatistics and Programming Departments. Acts as the lead programmer on multiple studies. Manages project timelines, budgets, and resources. Effectively assigns and communicates priorities and work direction to ensure completion of assigned tasks on time and within budget. Oversees the programming aspects of clinical trials from data extraction from trial databases through analysis and reporting, including integration of studies and submission data files. Actively contributes to process improvement efforts including the leadership of solution teams. Represents the department within the company and with interactions with client companies and regulatory agencies, as required. Involved in hiring, training, and mentoring staff. Leads multiple projects including mentoring programming team members and may be assigned direct reports including Senior Programming Analyst, Programmer Analyst, and Associate Programmer Analyst

Position Scope

Contributes directly to the company's revenue by developing staff; recruiting new staff; retaining existing staff; and coordinating & mentoring personnel to perform the programming and validation of deliverables. Successful completion of assigned tasks increases the likelihood of repeat business from a client and ongoing success in acquisition of new business.

Hiring Requirements:

Education and Experience:

-BA/BS degree in statistics, computer science, biostatistics, mathematics or related field.

-Minimum five years of SAS programming experience including 4 years clinical research or related experience.

-Demonstrated ability to successfully lead the programming elements of multiple clinical projects simultaneously.

-Must have experience mentoring personnel and coordinating the work of project teams.

-Must have experience serving as a lead programmer on multiple projects or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills and abilities.

Knowledge, Skills and Abilities:

- Advanced SAS programming skills and understanding of database structures.

-Good organizational skills across individual projects. Ability to independently and effectively organize, manage own and team work loads, and complete multiple assignments with challenging timelines.

-Ability to adapt and adjust to changing priorities.

-Excellent written and verbal communication skills.

-Ability to work in a multi-disciplinary team setting.

-Basic understanding of statistical principles applied to the design and analysis of clinical trials.

-Ability to contribute to development of policies. Ability to make decisions regarding programming on company policies and procedures.

-Excellent problem solving skills.

-Ability to supervise and mentor as shown by leadership of projects and team members.

-Demonstrated strong attention to detail.

-Ability to facilitate communications with clients, project teams, departments and staff.

-Awareness for project budget creation, including modifying for project updates.

-Ability to manage project budgets and risks.

-Knowledge of clinical trials, ICH Statistical and reporting guidelines and GCP.

-Delivery and Quality driven.

Supervisory Responsibilities:

Supervise the daily activities of a small unit or group of individual contributors performing the same or similar tasks where the majority of the time is spent performing the same or directly related individual tasks. Assigns, monitors and reviews progress and accuracy of work, directs efforts and provides technical guidance on more complex issues.

May be required to complete tasks of subordinates when the need arises. May initiate and communicate a variety of personnel actions (e.g. performance and salary reviews, time off requests, timesheet and expense report approvals).

Accountability Statements:

* Assume leadership responsibilities as a member of a multi-disciplinary project team.

* Provide Project Management on department projects. Communicate actively and frequently with other team members.

* Serve as a lead programmer on multiple projects.

* Manage project teams for multiple projects. This involves conducting team meetings, meeting project timelines, assessing resources needed, forecasting and input to budgetary needs. Ensure that SOPs are being followed and that appropriate project documentation is completed and maintained in an ongoing manner.

* Allocate and co-ordinate resources within the team to achieve timelines.

* Time management of own and team's time spent on projects.

* Independently create, execute, maintain, and validate programs that transfer data across multiple data management systems or operating systems, combine data froma variety of sources and structures, generate and store summary data from a variety of sources, generate reports or combine multiple databases.

* Contribute to and review statistical analysis plans, mainly through table, listing and graph specifications.

* Specify the general structure of the analysis database following industry guidelines, oversee its development, and ensure completeness for use in all programming. Provide programming support for the development of the analysis database.

* Produce, validate and review statistical appendices, with appropriate documentation. Contribute to and review results presented in statistical reports, integrated clinical/statistical reports, integrated summaries of safety/efficacy and other documents, as required.

* Provide the Project Manager, department management and company management with timely, accurate status and resourcing reports.

* Be familiar with any relevant contractual obligations or limits with our clients. Manage projects accordingly

* Interact with the sponsor on programming aspects of the project and present at meetings, as required.

* Be familiar with and follow the departmental and company standard operating procedures (SOPs) and working practice documents (WPDs). Contribute to their development as needed.

* Demonstrate a good understanding of the role of the programmer in the overall process.

* Monitor staff assignments, evaluating and shifting priorities and assignments to meet timelines and deliver high quality work. Provide feedback to management when timeline or resourcing constraints develop.

* Supervise assigned staff by providing employee development, completing performance reviews, planning and documenting development and training.

* Contribute to management as to hiring recommendations, department policies and resourcing requirements.

* Actively contribute to process improvements and department initiatives, including the leadership of initiative solution teams.

Sthree UK is acting as an Employment Agency in relation to this vacancy.