Sr Statistical Programmer II (Project Lead) Office or Remote
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
Based on leadership and/or technical competency, the Senior Statistical Programmer II will serve in the following capacity:-
either (project leadership track)
· Programming leadership for one high complexity programming project or at least two moderate complexity studies in parallel including effective resource planning, work allocation and progress tracking to ensure project timelines and quality targets are consistently achieved. In this client-facing role, the Senior Statistical Programmer II will invest in building long-term relationships with clients in a partnership role.
or (technical track)
· Apply outstanding technical capabilities to develop specific and broad-use/generic technical solutions e.g. macros, for the benefit of study teams across the enterprise
· Act as a Statistical Programming consultant to individual programming teams to resolve technical programming challenges that cannot be solved within the team
· Develop and deliver technical programming seminars on programming techniques, best practices and new developments in statistical programming software e.g. new SAS releases
Irrespective of leadership/technical track, the Senior Statistical Programmer II is also responsible for writing programming specifications and the development and validation/QC of statistical programs and applies extensive domain and therapeutic knowledge in the programming of datasets, tables, figures and listings to ensure quality and accuracy.
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.
Benefits of Working in ICON
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
Teaser label
Our PeopleContent type
BlogsPublish date
03/27/2024
Summary
Exploring Lucy's Path: From Science to Communications Lucy's career journey is a testament to the power of adaptability and seizing opportunities as they arise. "I've been in Clinical Research si
Teaser label
Career ProgressionContent type
BlogsPublish date
03/27/2024
Summary
Interviews can be nerve-wracking experiences, but with the right preparation, you can enter the room with confidence and increase your chances of success. Preparing for an interview is crucial a
Teaser label
Career ProgressionContent type
BlogsPublish date
03/27/2024
Summary
Clinical research plays a crucial role in advancing medical knowledge and improving patient care. At the heart of every successful clinical research study is a Clinical Research Coordinator (CRC
Who we are
Similar jobs
Salary
Location
Taiwan, Taipei
Department
Clinical Monitoring
Location
Taipei
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR118189
Expiry date
01/01/0001
Author
Candice WangAuthor
Candice WangSalary
Location
Korea, Seoul
Department
Study Start Up
Location
Seoul
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR117225
Expiry date
01/01/0001
Author
Daisy ParkAuthor
Daisy ParkSalary
Location
United States
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Logistics & Supplies
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109389
Expiry date
01/01/0001
Author
Brandon PupekAuthor
Brandon PupekSalary
Location
North Wales
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
North Wales
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Logistics & Supplies
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
2024-109391
Expiry date
01/01/0001
Author
Brandon PupekAuthor
Brandon PupekSalary
Location
Chile, Santiago
Location
Santiago
Remote Working
Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own
Reference
JR117112
Expiry date
01/01/0001
Author
Justin HovisAuthor
Justin HovisSalary
Location
United States
Department
Clinical Operations Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Contracts Administration
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109246
Expiry date
01/01/0001
Author
Brandon PupekAuthor
Brandon Pupek