SI-BONE® is focused on helping patients in one of the most under-served, under-diagnosed, and under-treated areas in orthopedics, the sacroiliac (SI) joint. SI-BONE developed an innovative, patented implant to fuse the SI joint. The iFuse Implant System® provides a less invasive alternative to traditional sacroiliac (SI) joint fusion surgery and has been used in over 90,000 procedures to date.

We are a medical device company that is focused on improving the lives of patients with sacroiliac pelvic conditions. We are looking for people who are passionate about our mission and who are willing to work hard to achieve it. We are also looking for people who are:

• Agile: We work in a fast-paced environment and need to be able to learn and adapt to change quickly.
• Creative: We embrace creativity, and we need people who are not afraid to challenge the status quo.
• Team Players: We roll-up our sleeves and work together as one team to achieve our goals.

General Responsibilities:

The Clinical Data Specialist (CDS) plays a key role in the lifecycle of SI-BONE’s clinical studies. This role contributes to the integrity and efficiency of clinical trial data through R-based analytics, data cleaning, study visit tracking, and Trial Master File (TMF) maintenance.

The CDS’s focus is to ensure data accuracy, reliability, and reproducibility in SI-BONE clinical studies. This includes routine reviews of clinical study data, generating data reports (tables, listings, figures) that enable manuscript preparation and maintenance of study-related TMFs.

The CDS is responsible for performing all duties in compliance with all applicable corporate policies and worldwide regulatory requirements as included in the scope of the SI-BONE Quality Manual.

The employee must act and conduct company business in an honest, ethical and lawful manner, consistent with the company’s policies and AdvaMed Code of Conduct. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.

Specific Responsibilities and Skills:

• Ensures compliance with SI-BONE Clinical Investigation Plans (CIP) and associated documents (i.e., Data Management Plan (DMP), Statistical Analysis Plan (SAP)).
• Routinely reviews clinical trial data using R to assist in the efforts to clean, validate and analyze trial data. This includes tracking of subject visit completion across clinical sites and trials.
• Flagging data discrepancies and working with Clinical Research Specialists for timely follow-up and resolution.
• Generate summary reports and visualizations for the clinical team and internal stakeholders.
• Contributes to the preparation of study manuscripts and abstracts and data management plans.
• Assists with Case Report Form (CRF) and electronic data capture (EDC) system development, validation, and maintenance.
• Collaborate with clinical and finance teams to ensure accurate visit-based payment processing.
• Maintain logs and ensure real-time visit data is aligned with protocol requirements.
• Audits and index trial essential documents in the trial master file (TMF) system to support quality control and audit readiness and ensure compliance with GCP standards and internal SOPs.
• Supports the SI-BONE Quality System, adheres to company policies, and performs mandated training on time.

Knowledge, Education and Experience:

• Skilled in R programming (experience with tidyverse, ggplot2, dplyr preferred)
• Strong problem-solving skills
• Understanding of statistics
• Agile and able to change direction as needed
• Ability to identify and solve problems independently
• Experience with EDC systems (e.g., Castor EDC, Medrio, Rave, REDCap, etc.) and clinical trial management software
• Bachelor’s degree in Data Science or a related field preferred

Expertise and Attributes:

• Self-starter is a must for this position
• Understanding of ICH-GCP principles.
• Ability to prioritize tasks and work independently in a deadline-driven environment.
• Organized and efficient, this person should be a true team player with excellent verbal and written communication skills.
• Knowledge and familiarity of applicable regulations/standards (e.g. ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971, ISO 14155) as required to perform the job function

Salary range: $33 - $37 hourly. This is a non-exempt position. The compensation range for this position is specific to the location and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors.