Sr Statistical Programmer II (Project Lead) Office or Remote

Job Functions:

The following responsibilities apply to the Senior Statistical Programmer II irrespective of whether on the project leadership or technical track

Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.

*As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

Travel (<5%) domestic and/or international.

*Read, ensure understanding and adhere to all assigned ICON SOPs and working procedures.

*Record all billable and non-billable time accurately into the appropriate time management system.

*Complete all assigned training, including any mandatory training courses in ICON’s Training Management System (iLearn) in compliance with ICON and departmental policies.

The Senior Statistical Programmer II will be aligned to a project leadership or technical track encompassing the following responsibilities:

either (project leadership track)

*Lead and execute programming deliverables on one project of high complexity and/or at least two projects of moderate complexity in parallel and ensure that competing priorities are  managed  appropriately. May act as overall Programming Lead for a complete program of studies for a small/moderate project.

• *Lead and manage the assigned programming team’s deliverables at the study and program level to ensure project objectives are met within budget, to agreed timelines and to the highest standard of quality.
• *Proactively plan for and implement effective resource planning, task allocation and tracking of workload in accordance with agreed KPIs and quality standards
• *Serve in a client-facing capacity that demonstrates the ability to anticipate client needs and implement innovative solutions, as appropriate.
• *Develop and foster client relationships through effective project management and communication.
• *Facilitate flow of information on study budgets and change order management in a timely and efficient manner.
• Keep management informed of project status in relation to quality, timelines and/or performance issues.

·         *Set-up and maintain the PDVD according to the procedures for Planning, Executing, Tracking and Documentation of Programming and Validation activities.

·         *Liaise effectively with other ICON functions (e.g., DM, MW), as required during the life of the project.

·         *Participate in the review of in-progress audit findings and implement corrective actions, as required.

·         Participate in audit meetings with sponsors, as required.

·         Monitor programming activities in terms of added value and controlling costs, as required.

• Support Business Development activities, including participation in sponsor calls and meetings. 

or (technical track)

• *Apply outstanding technical programming capabilities to develop efficient point solutions (e.g. complex SAS macros) for the benefit of individual study programming teams where particular technical expertise is not available within the team.
• *Lead/participate in the development and validation of broad-use technical solutions for the benefit of multiple study teams across the department.
• *Lead/participate in relevant IT/Statistical Programming technical projects with a focus on improving efficiency/cost-effectiveness of the department and/or overall organisation.
• *Lead/participate in the development of programming procedures, techniques and best practices.
• Select/evaluate/test commercial tools to meet department needs, provide technical assistance in migration projects, develop training materials for technical initiatives

The following responsibilities apply to the Senior Statistical Programmer II irrespective of whether on the project leadership or technical track:

• *Deliver high quality statistical programming outputs for all assignments that consistently meet study timelines, quality standards, sponsor and/or contractual requirements.
• *Adhere to programming specifications and study specific requirements, including completion and filing of required documentation.
• *Plan, organize and prioritize workload to ensure effective time management and adherence to project specific timelines.
• *Efficient use of SAS, and adherence to SAS programming guidelines.
• *Create listing and safety outputs (analysis datasets, tables, figures) to a high standard of quality and accuracy.
• *Validate listing and safety outputs (analysis datasets, tables, figures) per departmental procedures.
• *Create efficacy outputs (analysis datasets, tables, figures) to a high standard of quality and accuracy.
• *Validate efficacy outputs (analysis datasets, tables, figures) per departmental procedures.
• *Create complex programs (such as project or departmental macros) to a high standard of quality and accuracy.
• *Validate complex programs (such as project or departmental macros) per departmental procedures.
• *Create and maintain analysis dataset specifications to a high standard of quality and accuracy.
• *Set-up standard programming directories and start-up utilities.
• *Create, document and validate macros at the table, listing and figure level.
• *Trouble-shoot and resolve programming issues in a timely and efficient manner.
• *Proactively communicate and work effectively with the biostatistics team including remote teams and with senior programming, management and sponsor personnel to achieve study goals.
• *Strive for excellence and act in a proactive and responsive manner to internal and sponsor needs.
• *Demonstrate a constructive and flexible approach to project delivery, including problem solving, handling changing priorities and meeting study timelines.
• *Learn, share and apply new techniques and technologies to increase efficiency and to implement industry trend solutions (e.g., SDTM, ADaM)
• *Perform other project activities as required, including timely and accurate study file completion (electronic and paper).
• *Actively participate and contribute towards department initiatives, including sharing of knowledge, current literature reviews and process improvement.
• Preparation and delivery of presentations and attendance at appropriate scientific meetings and conferences

Supervision:

·         Assist Manager of Statistical Programming or designee in the interviewing and selection of staff in his/her group.

·         Serve as a mentor and help to train junior staff, including remote teams.

·         *Monitor overall quality and productivity of assigned programming team members (as appropriate to level/experience) and escalate to manager accordingly.

*Operate independently with a willingness to make decisions. Monitor progress and hold self and others accountable

Experience:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

·         US/LATAM/CAN:  A minimum of 8 years relevant experience of successfully performing the role of Statistical Programmer, preferably in the clinical research industry.

·         Prior experience of leading a programming team to manage timelines, resources and overall quality in a client-facing capacity (project leadership track only)

·         Demonstrated ability to perform assigned tasks independently and as part of a team.

·         Demonstrated ability to successfully manage complex assignments, including competing tasks and timelines.

·         Ability to liaise successfully with team members, management and externally with vendors and sponsors, as required.

·         Advanced problem solving and organizational skills, attention to detail, verbal and written communication skills.

·         Good understanding of global clinical trial practices, procedures, methodologies and regulatory requirements (e.g., GCP, ICH).

·         Strong working knowledge of the types of risks associated with a study and the impact on key parameters, such as study timelines (project leadership track only).

·         Demonstrated ability to learn new applications and techniques.

·         Advanced working knowledge of statistics and statistical software packages, including SAS.

·         Advanced working knowledge of statistical concepts.

·         Advanced/expert-level (project leadership/technical track, respectively) working knowledge of data structures (e.g., CDISC SDTM, ADaM), software development lifecycle and their implementation.

·         Advanced/expert-level (project leadership/technical track, respectively) working knowledge of the development and use of standard programs and macros.

·         Strong/outstanding (project leadership/technical track, respectively) SAS programming skills

·         Ability to critically review data and implement corrective action steps effectively

Education:

Bachelor’s degree, in a quantitative or scientific discipline, or local equivalent.