Senior Statistician – Remote Clinical Trials (SAS) Expert

Rqm-; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

RQM+ is a MedTech CRO accelerating innovation in patient care. We seek a Senior Statistician to provide statistical consulting for design and analysis of clinical studies, collaborating with biostatistics and medical staff to deliver interim and final analyses and reports.

You will serve as the primary biostatistics contact for sponsors, develop SAPs, analyze data with SAS and SPSS, ensure regulatory compliance, and supervise statistical services across studies in a remote work setting.

Qualifications

• 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.

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

Tools

SAS

SPSS

Job description

RQM+ is a MedTech CRO accelerating innovation in patient care. We seek a Senior Statistician to provide statistical consulting for design and analysis of clinical studies, collaborating with biostatistics and medical staff to deliver interim and final analyses and reports.

You will serve as the primary biostatistics contact for sponsors, develop SAPs, analyze data with SAS and SPSS, ensure regulatory compliance, and supervise statistical services across studies in a remote work setting.