Senior Statistician

Location: Puerto Rico

RQM+ is The Med Tech 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 Med Tech. We make Med Tech 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 Med Tech 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.
Looking for English & Germany speaking candidates in the EU or US

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…