Jobs at Bioforum the Data Masters

Lead and develop Clinical Data Programming and Systems teams to deliver clinical database builds, programming, data integrations/transfers, visualizations, and automation across global studies. Manage resources, budgets, quality, compliance (CDISC, CDASH, GCP), client relationships, and continuous process improvements while driving technical innovation and mentoring future leaders.

Lead design, build, test, and maintain clinical trial databases in EDC platforms. Translate protocols into eCRFs, edit checks, derivations, visit schedules, workflows, and validations. Support lifecycle activities, migrations, integrations, change requests, testing, go-live readiness, database lock/closeout, and mentor junior team members while ensuring regulatory and quality compliance.

Lead design, build, test, implement, and maintain clinical trial databases in EDC systems. Translate protocols into database specs, configure eCRFs, edit checks, workflows, roles and integrations, perform testing and validation, support go-live and post-production, manage change requests, and mentor junior builders while ensuring regulatory and quality standards.

Design, configure, test, implement, and support RTSM and EDC systems for clinical studies. Translate protocols into system specifications, manage randomization and supply workflows, lead testing and go‑live activities, resolve system issues, handle integrations, and mentor junior staff while ensuring blinding, inventory control, and compliance across study lifecycle.

Lead and support risk-based QA activities in a regulated clinical research environment: CSV/CSA, supplier audits, validation lifecycle deliverables, investigations, CAPA implementation, audit support, QA documentation, training, and cross-stakeholder collaboration to maintain compliance with global regulatory standards.

Lead and develop Clinical Data Management teams to deliver high-quality, compliant data management across global clinical studies. Oversee operational delivery, resource planning, process improvements, client relationships, and regulatory compliance (GCP/SOPs). Mentor staff, drive strategic initiatives, and collaborate with cross-functional teams to meet project and organizational objectives.

Design, develop, validate, and maintain clinical data management reports, patient profiles, listings, dashboards, and EDC reports. Support data review, discrepancy management, reconciliation of external data, cross-functional collaboration, documentation, quality control, process improvement, and mentorship of junior programmers.

Lead or contribute to statistical programming for clinical trials, focusing on SDTM/ADaM datasets and TLFs. Oversee quality, validation, and dataset specifications, communicate with sponsors, and provide guidance on programming requirements. Oncology experience and team leadership are advantageous.

Lead statistical programming for clinical trials: develop and review SDTM/ADaM conversions, analysis datasets, and TFLs per CDISC and study SAP; prepare submission documents, mentor team members, and follow SOPs. May manage project timelines, scope, budget, resourcing, and interact with customers.

Senior statistical programmer responsible for CDISC-compliant clinical data conversion, development and review of SAS programs for SDTM/ADaM/TFLs, preparing submission documents (Define.xml, Reviewers Guide), mentoring team members, and potentially managing project timelines, scope, budget, and client interactions while following SOPs.

Lead and supervise clinical data management activities across studies, ensuring data quality, validation, and regulatory compliance. Design eCRFs, define data checks, drive data cleaning and review processes, manage risks and escalations, produce documentation and reports, support QA/CAPA, and mentor/train the data management team while collaborating with internal and external stakeholders to meet timelines and deliverables.

Lead and/or perform statistical programming for clinical trials, create and review SDTM/ADaM specifications, program and validate datasets and TLFs, ensure quality and validation, and communicate with sponsors. Oncology experience and team leadership are advantageous.

Lead biometrics projects across clinical trials: plan scope, timelines, budgets and risks; coordinate cross-functional biometrics teams (biostatistics, data management, programming, medical writing); manage client communications, quality assurance, documentation, and process improvements; mentor junior PMs and contribute to business development and PMO SOPs.

Lead statistical aspects of clinical trials: design guidance, SAP and CSR statistical sections, SAS TLF development, ADaM/spec review, mentor junior statisticians, and interact with customers and regulators.

Lead and supervise data management teams across small-to-mid clinical studies, ensuring high-quality data workflows, regulatory compliance (GCP, FDA, CDISC), project delivery on time and budget, stakeholder and customer management, audit support, mentorship, and continuous improvement of DM processes and tools.