Associate Director - Clinical SAS Programming

Associate Director, Stat Programming (Grade 33)

Purpose :

- Manage a team of Statistical Programming (SP) staff including assisting in the hiring, training, and supervising of department members. May fulfill the role of site head or functional head within a site.

- Assist in directing the Statistical Programming (SP) department in the development of policies, procedures, and standards in support of project team efforts. Plan, schedule, and ensure adequate levels of training are carried out to meet workload requirements.

- Develop, recommend, and implement standard procedures, measures of performance, and training programs. Organize and allocate resources according to multi project requirements and deadlines. May serve as Lead on major projects.

Responsibilities :

Technical responsibilities :

- Serve as a Stat Programming consultant for other members of the department and staff members from other Biostatistics departments within the company.

- Maintain knowledge and awareness of developments in statistical programming.

- May participate as high level lead Stat Programmer on major project(s).

- Provide advanced technical expertise for internal and external clients.

- Independently bring project solutions to SP teams and the Statistical Programming department.

- Provide expert review of process and methodology development work with regard to SP standards and validation procedures.

- Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resource matters.

- Ensure the high quality and timeliness of deliverables from the Stat Programming department and ensure the high quality of the QC expert review process.

- Participate in project meetings; keep up-to-date on project issues; keep Director informed of project issues.

- Coordinate and participate in process improvements and interoffice/interdepartmental task forces; oversee collection and reporting of Stat Programming metrics, implementation of revised work practices, new guidelines, and new software tools as they become available.

- Effectively allocate at the site level so as to achieve target utilization rates and project realization rates.

- Manage project budget and resource requirements: understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage Out of Scope and provide revenue and resource forecasts for groups of studies, integrated summaries or eSubmissions.

- Participate in sales meetings as required; oversee proposal preparation; ensure that all proposals bid by the department have an adequate budget, and sufficiently detailed set of budget assumptions.

Required Knowledge, Skills And Abilities :

- Expert knowledge of SAS and technical database skills

- Knowledge of statistics and/or the clinical drug development process (Phase I - V)

- In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

- Excellent written and oral communication skills with good interpersonal skills

- Excellent problem solving skills

- Excellent presentation skills

- Sound judgement/decision making

- Ability to lead and motivate a team

- Ability to effectively delegate work

- Ability to effectively motivate other staff members

- Ability to establish and maintain effective working relationships with coworkers, managers and clients

- Ability to negotiate project deliverable timelines with client

- Strong ability to communicate problems/issues along with experience of developing action plans or alternatives for resolution

Minimum Required Education And Experience :

- Master's degree in computer science or related field and 7 years relevant experience including 2 years experience managing staff

- Bachelor's degree or educational equivalent in computer science or related field and 8 years relevant experience including 2 years experience managing staff or equivalent combination of education, training and experience

Physical Requirements :

- Extensive use of telephone and face-to-face communication requiring accurate perception of speech

- Extensive use of keyboard requiring repetitive motion of fingers

- Regular sitting for extended periods of time

- Occasional travel