Key Responsibilities: Leadership: Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company Represent sponsors at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee Participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication Participate as high level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries and/or NDA sections Leading studies at an operational level Provide expert review and initiate methodology development work with regards to statistical standards and validation procedures Consult on operational/statistical/therapeutic area topics Knowledge Sharing: Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses Performs as subject matter expert (SME) Risk Management: Identifies risks to project delivery and/or quality, leads in a way to minimize risks Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions Lock and Unblinding Process: Leads the database lock and unblinding process for the statistical team Participate on the biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules) Statistical Expertise: Provide expert statistical input into review of statistical deliverables (i.e. statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for complex and/or integrated reports) Provide expert input into data management deliverables (i.e. database design, CRF design, validation checks and critical data) Provide expert review of ADaM reviewers guide (ADRG) and metadata Perform senior biostatistical review (SBR) Produce or perform quality control review of sample size calculations for complex studies Requirements: Masters or PhD degree in Biostatistics or a related field with relevant experience within the life-science industry Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials Expert in strategically collaborating with clinical and drug development expertsExperience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Strong working knowledge of SAS or RExcellent knowledge of CDISC Data Standards Superb communication and collaboration skills Independent and pro-active problem solving skills IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Fresenius Digital Technology GmbH sucht in eine/n Senior Consultant Data Lake & Analytics Solutions (m/f/d) (ID-Nummer: 13745661)
Löwenstein Medical Technology GmbH + Co. KG sucht in eine/n ERP Inhouse Consultant (m/w/d) Schwerpunkt Vertriebsprozesse (ID-Nummer: 13665700)
Mit uns erhalten Sie die richtige Unterstützung für Ihren beruflichen Erfolg in Zusammenarbeit mit auf Ihre Branche spezialisierten Consultants. Dieses Know-how ermöglicht es uns, Sie individuell und passgenau bei der Planung Ihrer nächsten beruflichen Schritte zu unterstützen.
Brand Pier GmbH sucht in Hamburg eine/n Senior PR Manager / Senior Communications Consultant (m/d/w) (ID-Nummer: 13296377)
Für unser Analytics & Consulting Team suchen wir zum nächstmöglichen Zeitpunkt einen erfahrenen Senior Consultant am Standort Frankfurt am Main oder München. Als Engagement Manager übernehmen Sie die Leitung für unsere vielfältigen Beratungsprojekte und sind zentraler Ansprechpartner für unsere wesentlichen internen und externen Stakeholder.
In the last decades, we were able to support numerous IT experts with choosing the right path for a successful career, positioning ourselves as their lifelong partner. Our highly specialised consultants can cater to your every wish and expectation and will prepare you for interviews and contract negotiations. Give it a try and learn what the market has to offer – our services are free of charge, non-binding and discreet!
Medperion Communication GmbH sucht in eine/n PR Consultant Healthcare (m/w/d) (ID-Nummer: 13699005)
In the last decades, we were able to support numerous IT experts with choosing the right path for a successful career, positioning ourselves as their lifelong partner. Our highly specialised consultants can cater to your every wish and expectation and will prepare you for interviews and contract negotiations. Give it a try and learn what the market has to offer – our services are free of charge, non-binding and discreet!
In the last decades, we were able to support numerous IT experts with choosing the right path for a successful career, positioning ourselves as their lifelong partner. Our highly specialised consultants can cater to your every wish and expectation and will prepare you for interviews and contract negotiations. Give it a try and learn what the market has to offer – our services are free of charge, non-binding and discreet!
In the last decades, we were able to support numerous IT experts with choosing the right path for a successful career, positioning ourselves as their lifelong partner. Our highly specialised consultants can cater to your every wish and expectation and will prepare you for interviews and contract negotiations. Give it a try and learn what the market has to offer – our services are free of charge, non-binding and discreet!
koenig.solutions GmbH sucht in Walldorf eine/n Senior Consultant SAP for Utilities (ID-Nummer: 13095282)
Lufthansa Industry Solutions AS GmbH sucht in eine/n Senior Celonis Consultant (all genders) (ID-Nummer: 13411810)
DATAGROUP sucht in eine/n Senior SAP TM Consultant (all genders) (ID-Nummer: 13762235)
Deloitte sucht in eine/n Senior Consultant Immigration (m/w/d) (ID-Nummer: 13590336)
UMCO GmbH sucht in eine/n Senior Consultant (m/w/d) Gefahrstoffmanagement (ID-Nummer: 13698569)
WILO SE sucht in eine/n Senior Business Consultant (w/m/d) (ID-Nummer: 13763037)
CANCOM SE sucht in eine/n Senior Consultant Openshift (m/w/d) (ID-Nummer: 13334999)
CANCOM SE sucht in eine/n Senior Security Consultant (m/w/d) (ID-Nummer: 12627287)
BearingPoint GmbH sucht in eine/n (Senior) Consultant Technology (m/w/d) (ID-Nummer: 12337084)
SoftProject GmbH sucht in eine/n (Senior) Technical Consultant (m/w/d) (ID-Nummer: 13571566)
BearingPoint GmbH sucht in eine/n (Senior) Consultant | Banksteuerung (m/w/d) (ID-Nummer: 13724571)
Drees & Sommer SE sucht in eine/n (Senior) Consultant (w/m/d) Elektrotechnik (ID-Nummer: 12406910)
Drees & Sommer SE sucht in eine/n Senior Consultant (w/m/d) Rechenzentren (ID-Nummer: 13132803)
Drees & Sommer SE sucht in eine/n Senior Consultant (w/m/d) Energiedesign (ID-Nummer: 12704440)
Liebherr-Components GmbH sucht in eine/n Senior Consultant für Fabrikplanung (m/w/d) (ID-Nummer: 13787533)
Porsche Consulting GmbH sucht in eine/n (Senior) Consultant (all genders) - Operations in der Konsumgüterindustrie (ID-Nummer: 13741578)
msg life ag sucht in eine/n (Senior) Consultant Geschäftsprozesse Lebensversicherung (all genders) (ID-Nummer: 13667517)
Vicondo Healthcare GmbH sucht in Berlin eine/n (Senior) Consultant Healthcare (m/w/d) (ID-Nummer: 13691501)
Galahad SNR GmbH sucht in Berlin eine/n (Senior) Recruitment Consultant (m/w/d) (ID-Nummer: 13686170)
Publicis Media GmbH sucht in Düsseldorf eine/n Senior Data Consultant (m/w/d) (ID-Nummer: 13722131)
HPM Service und Verwaltung GmbH sucht in eine/n (Senior) Software Consultant (m/w/d) (ID-Nummer: 13560403)
Leyton Deutschland GmbH sucht in München eine/n (Senior) Technical Consultant (m/w/d) (ID-Nummer: 13746407)
Lufthansa Industry Solutions AS GmbH sucht in eine/n Senior Power Platform Consultant (all genders) (ID-Nummer: 13385434)
Senior Consultant SAP TM (w/m/d)
SEVEN PRINCIPLES GROUP sucht in Stuttgart, Köln, Frankfurt oder Hamburg eine/n (Senior) Atlassian Consultant (m/w/d) (ID-Nummer: 13720747)
KPMG AG Wirtschaftsprüfungsgesellschaft sucht in München, Frankfurt, Hamburg, Düsseldorf, Berlin, Stuttgart eine/n Senior Consultant Transaktionsberatung (w/m/d) (ID-Nummer: 13313546)
KPMG AG Wirtschaftsprüfungsgesellschaft sucht in München, Frankfurt, Hamburg, Düsseldorf, Berlin, Mannheim eine/n Senior Consultant IT-Audit Financial Services (ID-Nummer: 13313560)
Senacor Technologies AG sucht in Berlin, Bonn, Frankfurt, Hamburg, München, Nürnberg, Wien eine/n Senior IT Consultant (m/w/d) (ID-Nummer: 7864161)
Senacor Technologies AG sucht in Berlin, Bonn, Frankfurt, Hamburg, München, Nürnberg, Wien eine/n (Senior) Consultant - Insurance (m/w/d) (ID-Nummer: 8300658)
Senacor Technologies AG sucht in Berlin, Bonn, Frankfurt, Hamburg, München, Nürnberg, Wien eine/n Senior Consultant IT Strategy & Digital Transformation (ID-Nummer: 8789049)
TELEKOM HEALTHCARE SOLUTIONS Deutsche Telekom Clinical Solutions GmbH sucht in Köln, Bochum oder Bensheim eine/n Senior IT Consultant (m/w/d) (ID-Nummer: 5659965)
PwC sucht in eine/n Senior Consultant Accounting- und Kapitalmarktberatung (w/m/d) (ID-Nummer: 13762563)
DATAGROUP sucht in eine/n Senior SAP FI/CO Consultant (all genders) (ID-Nummer: 13762502)
Deloitte sucht in eine/n Senior Consultant ServiceNow HRSD (m/w/d) (ID-Nummer: 13562609)
Deloitte sucht in eine/n Senior Consultant Regionalbankberatung / Restrukturierung (m/w/d) (ID-Nummer: 13623213)
BridgingIT GmbH sucht in eine/n (Senior) Consultant Cyber-Security (w|m|d) (ID-Nummer: 13785808)
Sopra Steria sucht in eine/n Senior Consultant Registermodernisierung (RegMoG) (m/w/d) (ID-Nummer: 13325606)
Diehl Aviation sucht in eine/n Senior AI Solution Consultant (m/w/d) (ID-Nummer: 13578189)
Sopra Steria sucht in eine/n Senior Consultant SAP TRM (m/w/d) (ID-Nummer: 13387930)