Brunel Service GmbH & Co. KG
Celonis SE
NTT DATA Deutschland GmbH
NTT DATA Deutschland GmbH
NTT DATA Deutschland GmbH
Reply AG
Rau Consultants GmbH
INFOMOTION GmbH
NTT DATA
OBI Group Holding SE & Co. KGaA
GK SOFTWARE SE
Magirus GmbH
Horváth
All for One Group AG
NTT DATA Deutschland GmbH
COSMO CONSULT AG
tts GmbH
OPITZ CONSULTING Deutschland GmbH
HAPEKO Deutschland GmbH
ABOUT YOU GmbH & Co. KG
Hays AG
PSC Pro Search Consulting GmbH Unternehmensberatung
NTT DATA Deutschland GmbH
EuroEyes Deutschland Holding GmbH & Co. KG
SCHOTT AG
A+W Software GmbH
A+W Software GmbH
PRIMEPEOPLE AG
NTT DATA Deutschland GmbH
SCHOTT AG
IQVIA Commercial GmbH & Co. OHG
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.
Hays AG
GK SOFTWARE SE
GEFA BANK GmbH
Hays AG
Rau Consultants GmbH
RAU | CONSULTANTS is not in charge of this search project.
Hays AG
Hays AG
ams Sensors Germany GmbH
Hays AG
TFP Fertility Germany GmbH
CSL Behring GmbH
teamative Germany GmbH
ABOUT YOU GmbH & Co. KG
teamative Germany GmbH
Conductix-Wampfler GmbH
Sales professional with budget responsibility and/or business development and/or key account management experience Track record in leading teams Industry experience in Industrial Mobile Robots, Automated Guided Vehicles and/or Autonomous Mobile Robots working for an OEM, system integrator or a major components or systems supplier Exceptional communication and stakeholder management skills, with the ability to effectively engage and influence cross-functional teams, as well as senior management Solid experience in project planning, budgeting, resource management, and risk mitigation Strong problem-solving and decision-making abilities, with a focus on delivering results even in challenging situations Critical and strategic thinking What you can expect from us: What you can expect from us: 40 hours per week and 30 days vacation Flextime and family-friendly company Business Bike (EBike) Yearly Bonus payment depending on the success of the company Vacation pay and Christmas bonus Remote possible on a pro rata basis Additional contribution to company pension scheme Subsidized meals in the canteen Travel allowance from 20km distance 24-hour accident insurance for work and private life Individual development opportunities Employee parking lot with charging stations for e-cars Employee discounts (via corporate benefits portal) Interessiert?
Rau Consultants GmbH