Clinical Database Analyst Integrated Resources, IncClinical Database AnalystLexington, MassachusettsFull timePOSITION SUMMARY: Responsible for visualizing clinical trial data in SPOTFIRE for the Analytical Risk-based Monitoring (ARBM) group and for the medical reviewers in the iDARTs application (an internally developed tool for medical review of clinical trial data based on TIBCO's Spotfire). o Collect additional user requirements (from study physicians & data managers) and design new visualizations (Tables/Graphs).
Biostatistician Integrated Resources, IncBiostatisticianWoodcliff Lake, New JerseyFull timeWork with the project statistician and clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality. Work closely with clinicians, programmers, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review.
Senior Bio statistician Integrated Resources, IncSenior Bio statisticianWoodcliff Lake, New JerseyFull timeWork with the project statistician and clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality. • Work closely with clinicians, programmers, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review.
Senior Biostatistician Integrated Resources, IncSenior BiostatisticianWoodcliff Lake, New JerseyContractorSenior Biostatistician Description: • Work closely with clinicians, programmers, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review. • Work with the project statistician and clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality.
Associate Director, Clinical Development Advanced Recruiting PartnersAssociate Director, Clinical DevelopmentNew York, GA$169,814–$192,241 / yearThe lead product candidate, lysergide tartrate, represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Guided by the recognition that patients deserve more than better, the company is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders.
Clinical Data Standards Manager SDTM Dale Workforce SolutionsClinical Data Standards Manager SDTMThousand Oaks, CARemoteEnsure that decisions with respect to SDTM implementation are CDISC-compliant and are in line with industry and regulatory guidance. Preferred Qualifications: • 10 or more years of pharmaceutical/biotech experience in data management, biostatistics or programming.
NewBiostatistics Consultant Sunrise Systems IncBiostatistics ConsultantMarlborough, MARemote$60–$70 / hourResponsibilities include reviewing and finalizing analysis datasets, supporting data quality and consistency checks, conducting or validating statistical analyses, generating tables, figures, and listings, interpreting statistical results, and contributing to statistical content to be used for publications. The consultant will collaborate with cross-functional team members, address publication-related statistical questions, and help ensure analyses and outputs are scientifically rigorous, accurate, and publication-ready.
Biomedical Data Stewardship Manager Aditi ConsultingBiomedical Data Stewardship ManagerThousand Oaks, CARemote$60–$62 / hourConsent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts.
NewRemote Biostatistics Consultant | Part-Time Sigma IncRemote Biostatistics Consultant | Part-TimeMarlborough, MARemoteThis role will work closely with medical strategy leaders, publication specialists, statistical programmers, and cross-functional research teams to ensure analyses are scientifically rigorous, accurate, and ready for regulatory and publication use. This part-time consulting opportunity is ideal for a biostatistician with strong clinical trial experience, advanced statistical expertise, and the ability to collaborate with cross-functional teams to deliver high-quality, publication-ready analyses.
Recruiter Advanced Recruiting PartnersRecruiterSouth San Francisco, CARemote$50–$60 / hourThe ideal candidate has a strong understanding of clinical research roles, industry terminology, and the qualifications required for positions across Clinical Operations, Regulatory Affairs, Data Management, Biometrics, Medical Affairs, and related functional areas. This role will be dedicated to recruiting clinical research professionals across a variety of functions while working in close partnership with an external recruiting agency.
Biostatistician Manager Integrated Resources, IncBiostatistician ManagerWoodcliff Lake, New JerseyContractorProject work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans. Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others.
Statistician Karwell TechnologiesStatisticianNewark, NJProvides general infrastructure support to the Department (presents / teaches at the department meetings, contributes to other general department documents or policies, assists with newsletter, helps in department libraries, or trains new hires). Supports the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies.
Bio Statistician Karwell TechnologiesBio StatisticianFoster, CAProvides general infrastructure support to the Department (presents / teaches at the department meetings, contributes to other general department documents or policies, assists with newsletter, helps in department libraries, or trains new hires). Supports the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies.
Statistician Katalyst Healthcares & Life SciencesStatisticianJersey, NJProvides general infrastructure support to the Department (presents / teaches at the department meetings, contributes to other general department documents or policies, assists with newsletter, helps in department libraries, or trains new hires). Supports the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies.
Senior Biostatistician Katalyst Healthcares & Life SciencesSenior BiostatisticianRemote, NJRemoteProvides general infrastructure support to the Department (presents / teaches at the department meetings, contributes to other general department documents or policies, assists with newsletter, helps in department libraries, or trains new hires). Supports the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies.
Bio Statistician Katalyst Healthcares & Life SciencesBio StatisticianFoster, CAProvides general infrastructure support to the Department (presents / teaches at the department meetings, contributes to other general department documents or policies, assists with newsletter, helps in department libraries, or trains new hires). Supports the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies.
Clinical Data Associate - II Integrated Resources, IncClinical Data Associate - IIFoster City, CaliforniaContractorWorks collaboratively with Clinical Programmers, CRA, Statistical Programmers, Biostatisticians and other Clinical, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. Assists in the implementation of routine clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery.
Clinical Research Associate Integrated Resources, IncClinical Research AssociateSan Jose, CaliforniaContractorCandidate with Academic CRO experience would also be fine, leading the study(3-4 studies) Understands data management and documentation process Candidate who has worked on clinical trials as clinical data manager, CRF design and clinical data management plan, study maintenance Works with Clinical Programmers, CRA, Statistical Programmers, Biostatisticians and other Clinical, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. Assists in the implementation of routine clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery.
Prin Statistician Artech LLCPrin StatisticianMounds View, MN$70–$75 / hourSupport clinical trial design, regulatory submissions (FDA/global), and interpretation of study results. Perform sample size/power calculations, statistical modeling, and data analysis using SAS and/or R .
Manager, Clinical Programming (Remote) Penfield Search PartnersManager, Clinical Programming (Remote)Fairfield, CTRemoteWe are seeking an experienced Senior Clinical Programmer to support clinical development programs by delivering high-quality programming solutions for medical monitoring, data management, and statistical programming activities. This role partners closely with cross-functional teams to develop efficient, compliant, and scalable programming solutions that support ongoing clinical trials.