RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.

We don’t make MedTech. We make MedTech happen.

Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency.

Job Summary:

The Senior Statistician provides statistical consulting and technical support as it relates to the design and statistical analysis of clinical studies. Perform analysis, interpret study results, and collaborate with medical and biostatics staff to product interim and final analyses and reports. May be responsible for more than one study.

Primary Responsibilities:

• Collect and analyze empirical data of clinical trials, prepare and present it.
• Serve as a biostats contact for the sponsor of the assigned duties
• Comply with legal requirements and international guidelines
• Comply with RQM+ policies and standards.
• Comply with project requirements.
• Professional knowledge of the study experiment about statistical experiments.
• Being the contact person for clients on all statistical issues in clinical trials
• Responsible for drawing up statistical analyses plans and detailed tables / data specifications and collaborate in the preparation of study protocols and study reports
• To get the knowledge of the study contract and all other relevant study information
• Calculation of sample sizes
• Programming with SAS (and SPSS)
• Preparing the statistical sections of study protocols, statistical analysis plans, unblinding authorization documents, conflict of interest statements (interim analyses), biostatistical reports (incl. interim reports) and statistical parts of a client study report
• Responsible for supervision of statistical services
• Monitoring the quality and program the statistical evaluation of clinical trials
• To classify all protocol deviations concerning its impact on the efficacy analysis (minor /major)
• Conducting unblinding procedures
• Active providing of statistical analyses to our clients

Education/Work Experience/Requirements:

• Academic degree in mathematics or statistics and several years of experience in a similar role
• Understanding of Good Clinical Practices (GCP) and applicable AMG rules, guidance and governance as it relates to early phase human clinical trials.
• Advanced experience in SAS programming
• Strong knowledge of relevant regulatory guidelines and CDISC standards.
• Experience in preparation of statistical analysis plans (SAPs)
• Experience in programming ADaM datasets and in preparation of the supporting documents.
• Experience in conducting (adaptive) interim analyses and final analyses including preparation and support of Data Review Meetings.
• Experience in preparation of statistical reports and of statistical and result sections of a study report
• Experience in customer support (study teams, sponsors)
• Ability to be the contact person for clients on all statistics
• Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC ADaM
• Strong experience working with SAS
• Experience using standardized medical terminology, as a statistician' including MedDRA and WHODrug
• Ability to work independently
• Bilingual skills required, German and English.

Behaviors: Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

Supervisory Responsibilities: This position does not have supervisory responsibilities.

Work Environment & Physical Requirements:

This is a remote position. The employee is expected to maintain a dedicated, distraction-free home workspace with reliable high-speed internet access. Core working hours are determined by role responsibilities, client expectations, and business needs.

These requirements reflect what's typically needed to perform the core functions of this role. If you require an accommodation to perform any aspect of this position, please let us know — we're happy to discuss options.

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

We are committed to promoting equality of opportunity for all staff and job applicants. We aim to create a working environment in which all individuals can make best use of their skills, free from discrimination or harassment, and in which all decisions are based on merit.

Our selection for recruitment does not discriminate based on age, disability, gender reassignment, marital or civil partner status, pregnancy or maternity, race, color, nationality, ethnicity, ethnic or national origin, religion or belief, sex or sexual orientation or gender reassignment status (protected characteristics).

Job Opportunity Verification:

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

• All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers
• Every candidate going through the interview process will participate in a voice and/or video interview.
• Exercise caution with unsolicited job offers or requests for sensitive information.