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Data scientist (translational data, transfers & statistics – phase i)

Basel
Ridgeline Discovery
Data Scientist
Inserat online seit: 10 Juni
Beschreibung

Ph3About GRANITE BIO /h3 pGRANITE BIO is a private biotechnology company located in Basel, Switzerland, developing innovative monoclonal antibodies to treat inflammatory, autoimmune, and fibrotic conditions. /p h3Role Overview /h3 pWe are seeking a Data Scientist with strong expertise in data transfers (DTS), statistical analysis, and translational data integration to join our Translational Science team. This role supports the progression of programs in early clinical development (Phase I). Responsibilities include end‑to‑end data lifecycle management, building scalable pipelines, ensuring data quality, and applying advanced statistical methods to generate actionable insights for first‑in‑human studies. /p h3Responsibilities /h3 ul liApply advanced statistical methods to analyze integrated preclinical, biomarker, and clinical datasets /li liDevelop and implement statistical models supporting translational and exploratory analyses /li liContribute to and review Statistical Analysis Plans (SAPs) focusing on early‑phase and biomarker‑driven studies /li liSupport decision‑making (dose escalation, cohort expansion) through data‑driven insights /li liPerform exploratory analyses linking PD, biomarkers, and clinical outcomes /li liDesign, implement, and oversee data transfer specifications (DTS) across internal systems and external partners /li liEnsure seamless ingestion and harmonization of multi‑source datasets (preclinical, clinical, omics, biomarker) /li liEstablish and maintain robust ETL pipelines and data workflows /li liEnsure data consistency, traceability, and auditability across systems and studies /li liCollaborate with CROs and vendors to ensure timely, high‑quality data delivery and transfers /li liOversee data management activities for Phase I trials with emphasis on complex and exploratory datasets /li liDefine and enforce data standards, structures, and validation rules (e.g., CDISC where applicable) /li liReview key documents (DMPs, CRFs, data transfer agreements/specifications, validation plans) /li liEnsure data readiness for analysis, database lock, and regulatory submissions /li liEnsure compliance with ICH‑GCP and relevant data standards /li liSupport regulatory documentation and submissions involving biomarker and translational data /li liContribute to development of scalable, fit‑for‑purpose data science and DTS processes /li /ul h3Qualifications /h3 ul liMSc or PhD in Data Science, Statistics, Biostatistics, Bioinformatics, or a related field /li li5+ years of experience in data science, statistical analysis, or clinical/translational data environments /li liStrong experience with data transfers (DTS), ETL processes, and data pipeline development /li liProficiency in statistical programming (e.g., R, Python, SAS) /li liExperience with early‑phase clinical development /li liSolid understanding of biomarkers, PK/PD relationships, and data integration across domains /li liFamiliarity with CDISC standards (SDTM/ADaM) and/or exploratory/non‑standard datasets /li liExperience with ICH‑GCP and relevant standards /li liExperience with clinical early‑phase studies /li /ul h3What We Currently Offer /h3 h3Prime Location /h3 pModern laboratories and offices are located in Tech Park Basel – a leading hub for early‑stage start‑ups. /p h3Commuter Benefits /h3 pWe support your individual commuting needs with parking options or a commuter allowance. /p h3Flexible Working /h3 pWe offer flexible working arrangements where possible. /p h3Additional Time Off /h3 pIn addition to 24 days of annual leave, our offices and labs are closed between Christmas and New Year. /p h3Your Birthday Off /h3 pEnjoy an extra day off to celebrate your birthday. /p h3Coffee Connection /h3 pFree coffee and a great space to connect with colleagues. /p h3Personal Development /h3 pWe support your professional and personal growth. /p h3Creative Environment /h3 pWork in an innovative, dynamic, and creative setting. /p h3Diverse Team /h3 pJoin an international team of passionate and talented people. /p h3Team Events /h3 pRegular off‑site summer and winter events to connect and have fun together. /p /p #J-18808-Ljbffr

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