Statistical Programmer

Statistical Programmer

Date: Aug 14, 2024

Req ID: 3563

Location:

Sunrise, FL, US

Company:

Department:

At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.

The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.

Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associates role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.

JOB TITLE

Statistical Programmer

DEPARTMENT

Clinical Affairs

JOB CODES

Job Codes assigned to Associates can be viewed on MasterControl via the Trainee Infocard

MAIN PURPOSE OF JOB AND OBJECTIVES

Develop SAS programs for the data management and statistical reporting of clinical study data.

POSITION IN ORGANISATION

Position in organization can be found on the Organizational Chart via the company intranet.

KEY DUTIES

• Develop, test and run SAS programs for statistical analysis and reporting of clinical study data. This includes programs for derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings

• Specification of table templates, writing of derived dataset specifications, production and formatting of tables and figures

• Develop, test, document and update SAS macros for the generation of summary and statistical analysis tables and figures for reports

• Develop SAS programs/macros for data cleaning and liaise with Data Management team in identifying and implementing checks according to the Data Validation Plan

• Perform ad hoc programming tasks to assist with data review and produce ad hoc summaries when requested during the course of a clinical study

• Document standard SAS programs to further develop quality of code and efficiency throughout the reporting and data validation processes

• When necessary, develop SAS programs for external data transfer

• Liaise with IT and external software providers on the procurement and installation of new software. Validate software in the role of system tester, maintaining the required validation and testing documentation

• Provide technical support and mentoring for colleagues

• Prepare, maintain, and archive programming documentation

• Establish and maintain SOPs related to programming

• Implement programming process improvements and identify opportunities for improving the efficiency and quality of work within Clinical Affairs

• Remain up to date on new SAS developments relevant to clinical study data and further develop knowledge of SAS (Base and SQL) and other software applications (e.g. Excel, visual basic), clinical data management and statistical reporting activities. Develop regulatory standards knowledge in computer systems, systems validation, GCP, CDM, clinical/statistical reporting and regulatory submission requirements

• Contribute to on-boarding of new associates and act as a mentor for junior staff

DIMENSIONS & LIMITS OF AUTHORITY

COMPANY

REQUIREMENTS

• Must work within requirements of company handbook and policy statements

Note: Company Handbook, Policy Statement and Authorization of Limits do not form part of the quality system

QUALITY

REQUIREMENTS

• Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives

• Work within the QMS at all times, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality

• Responsible to ensure facility, processes and documentation remain in a state of audit readiness at all times

EH&S REQUIREMENTS

• Take care of your own health and safety and that of others who may

be affected by your actions

• Work co-operatively to highlight issues affecting Environmental Health and Safety

QUALIFICATIONS & EXPERIENCE

• Degree in a relevant field (necessary)

• A minimum of 2 years' experience in the Clinical Research/Statistical Programming environment (necessary)

• Strong experience with data and production of Tables, Figures and Listings (necessary)

• Strong SAS programming and logic skills (necessary)

• Thorough understanding of CDISC standards (desirable)

• Thorough knowledge of clinical database structures (desirable)

• Experience in medical device, pharmaceutical or CRO industry (desirable)

• Experience of clinical trials involving medical devices (desirable)

• Proficient with MS Office applications (desirable)

• Excellent organizational and communication skills (desirable)

It is Terumos policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.