Berufsbezeichnung:
Project Manager Biostatistics & Data Management (m/f) Arbeitsort: Basel

Arbeitsbeschreibung:
Our client is a Switzerland-based biopharmaceutical company focused on the development of antibiotics, antifungals and oncology drugs. The company has a portfolio of marketed drugs as well as an innovative early and late-stage pipeline. For our client we are currently hiring a Project Manager Data Management & Statistics (m/f) office-based in Basel, Switzerland. Duties and responsibilities: Responsible to manage contract research organizations (CROs) performing data management and statistical tasks for clinical studies. To ensure that the deliverables are provided on time, to a high level of quality and adhering to client¿s requirements and to support clinical review of study data in SAS. ¿ Actively manage studies performed by CROs for Data Management and Statistics (contracts, payments, timelines, quality, cost and deliverables) ¿ Review and approve Data Management and Statistics study deliverables provided by the CRO (eCRF/database set-up, data management plan, statistical analysis plan, datasets (CDISC), tables, figures and listings) in order to ensure compliance with the study protocol and company standards ¿ Lead study team review of Data Management and Statistics deliverables ¿ Provide regular feedback to the study team on study progress and activities at the Data Management and Statistics CRO ¿ Regular review of study data with clinical team/ safety team. Support clinical review of data in SAS (JMP /JMP Clinical) ¿ Lead database lock plans and activities ¿ Coordinate development of the PK analysis between the Clinical Pharmacologist and the Statistics CRO ¿ Perform ongoing filing of study documentation and data in document management system ¿ Follow departmental policies, procedures, and SOPs Requirements: ¿ Extensive knowledge of all aspects of data management for all phases of studies, in particular Phase III global registration trials ¿ Good knowledge of the development of randomization lists, statistical analysis plan, allocation to analysis populations and the content of clinical study output ¿ Experience in regulatory submissions which include datasets is preferred ¿ Fluent written and spoken English. Knowledge of German or another European language is also an advantage ¿ Good knowledge of SAS programming. Experience in SAS JMP/JMP Clinical an advantage ¿ Good knowledge of SDTM and CDASH standards. ¿ Strong Leadership skills ¿ Team worker ¿ Flexibility ¿ Good organizational skills ¿ Able to work without supervision and to take responsibility for tasks ¿ Good written and verbal communication skills ¿ Risk awareness Why this vacancy is right for you: Our client offers an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life. Interested? Please submit your CV to przemyslaw.brzezinski (at) docsglobal.com. We are looking forward to getting to know you. - Kenntnisse und Fertigkeiten: Bioinformatik; Biometrie; Datenanalyse; Datenbankadministration, -management, -organisation; Entwicklung; Projektmanagement

Stunden pro Woche: 40

Angestelltenname: DOCS International Germany GmbH

Arbeitgeber-Adresse: Theresienhöhe 28, D-80339 München, Deutschland

Form von Kontakt: Przemyslaw Brzezinski

Arbeitgeber Telefonnummer: +49 89 244407115

Stellenkurzbeschreibung:
Mathematiker, Versicherungsmathematiker und Statistiker

Land: Schweiz

Region: Nordwestschweiz

Vertragslaufzeit: Unbefristet

Vertragstyp: Vollzeit

Erforderliche Ausbildung: Keine Angabe

Erfahrung: Gefordert

Quelle des Stellenangebots: BA, Öffentliche Arbeitsverwaltungen, Deutschland

Wie Sie sich bewerben: Weitere Angaben (siehe Beschreibung)

Gehalt Währung: EUR

Gehaltsperiode: monatlich

Gehalt Besteuerung: brutto