Skills and Abilities: Ability to identify additional service/system requirements or shortfalls and co-ordinate and/or design the delivery of innovative solutions to maximise service quality, efficiency and continuity. Ability to ensure professional and quality service standards are maintained and applied within own area of activity.
This role requires a highly experienced biostatistician capable of working independently, representing the Biostatistics function within cross‑functional teams, and delivering high‑quality statistical input throughout study design, execution, and analysis. Key Responsibilities Statistical Leadership & Study Support Serve as the primary statistical lead and main point of contact on the Clinical Trial Team (CTT), representing Biostatistics with confidence and professionalism.Work independently to support clinical teams, providing proactive statistical guidance throughout the study lifecycle.Lead statistical strategy discussions, including endpoint definitions, analysis methods, risk mitigation, and regulatory expectations.
Experience in set-up and conduct of Phase II clinical trials including in depth knowledge of early phase study designs, protocol writing and clinical pharmacology. Additional experience in conduct of Phase I and Phase III trials would be an advantage.
The Study Physician ensures state-of-the-art medical oversight from the Trial Design Outline (TDO) kickoff through to the Clinical Trial Report (CTR) and serves as a core member of both the Trial Team and the Evidence Network Team.
Your assignments Water treatment and desalination projects: study, design and supervision Short- and medium term assignments in English and/or French/Spanish speaking countriesCoordinate and expand desalination expertise within the organisation Your responsibilities Studies, design, tender documents and supervision for water desalination projects Being part of multidisciplinary teams Management of technical deliverables and reporting Your profile University degree in engineering or degree of similar level (B.Sc., M.Sc., PhD)At least 5 years of profound professional experience in desalination (SWRO)Experience with other technologies (MED, MSF), would be an advantage Experience in process and hydraulic engineering in water supply Experience relevant to assignments in developing countries desirableVery good command of the English and/or French/Spanish languagePrepared for worldwide travelling Flexible attitude We offer Interesting international projects (public and private Clients)Friendly international working environmentWorking in multidisciplinary teamshigh degree of personal responsibility Period of appointment: unlimited, the position is also available for freelance experts.
Register with us and reap the benefits of interesting job offers that match your skills and experience. Design, conduct, and analyze in vivo studies involving intravenous injections, blood collection, and bleeding/thrombosis models Execute full end-to-end in vivo workflows, from study preparation to sample processing and documentation Characterize gene therapy candidates using molecular and biochemical assays such as ELISA, thrombin generation, and chromogenic assays Handle, prepare, and evaluate patient-derived blood and plasma samples for in vitro and ex vivo experiments Perform data analysis, interpret results, and present findings to the research team Maintain accurate, complete, and compliant documentation across all experimental steps Contribute to lab operations, including safety standards, inventory, equipment handling, and general organization Collaborate with cross-functional team members to ensure smooth coordination and progress on gene therapy studies Academic background in life sciences (MSc or BSc) or completed scientific apprenticeship with hands-on laboratory experience Active certification for animal experimentation (e.g., LTK1, FELASA, or equivalent) Proven hands-on experience with rodent work, including intravenous injections and blood sampling Ability to independently design, execute, and manage in vivo studies from start to finish Experience with molecular or biochemical assays relevant to hemostasis, thrombosis, or gene therapy Strong ability to plan experiments, analyze data, and interpret scientific results Fluency in English with clear communication skills Highly organized, proactive, and team-oriented mindset with strong reliability and attention to detail Opportunity to contribute directly to translational gene therapy research with high scientific impact Hands-on work with a combination of in vivo, ex vivo, and molecular biology techniques Collaborative environment with close teamwork and modern laboratory infrastructure Diverse and meaningful daily tasks involving both preclinical models and human biological samples Ihr Kontakt Referenznummer 865654/1 Kontakt aufnehmen Telefon:+41 44 225 50 00 E-Mail: positionen@hays.ch Anstellungsart Freiberuflich für ein Projekt
Register with us and reap the benefits of interesting job offers that match your skills and experience. Design, conduct, and analyze in vivo studies involving intravenous injections, blood collection, and bleeding/thrombosis modelsExecute full end-to-end in vivo workflows, from study preparation to sample processing and documentationCharacterize gene therapy candidates using molecular and biochemical assays such as ELISA, thrombin generation, and chromogenic assaysHandle, prepare, and evaluate patient-derived blood and plasma samples for in vitro and ex vivo experimentsPerform data analysis, interpret results, and present findings to the research teamMaintain accurate, complete, and compliant documentation across all experimental stepsContribute to lab operations, including safety standards, inventory, equipment handling, and general organizationCollaborate with cross-functional team members to ensure smooth coordination and progress on gene therapy studies Academic background in life sciences (MSc or BSc) or completed scientific apprenticeship with hands-on laboratory experienceActive certification for animal experimentation (e.g., LTK1, FELASA, or equivalent)Proven hands-on experience with rodent work, including intravenous injections and blood samplingAbility to independently design, execute, and manage in vivo studies from start to finishExperience with molecular or biochemical assays relevant to hemostasis, thrombosis, or gene therapyStrong ability to plan experiments, analyze data, and interpret scientific resultsFluency in English with clear communication skillsHighly organized, proactive, and team-oriented mindset with strong reliability and attention to detail Opportunity to contribute directly to translational gene therapy research with high scientific impactHands-on work with a combination of in vivo, ex vivo, and molecular biology techniquesCollaborative environment with close teamwork and modern laboratory infrastructureDiverse and meaningful daily tasks involving both preclinical models and human biological samples Ihr Kontakt Referenznummer 865654/1 Kontakt aufnehmen Telefon:+41 44 225 50 00 E-Mail: positionen@hays.ch Anstellungsart Freiberuflich für ein Projekt
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.
Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, logistics challenges, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
You can expect to use your strong design background to broaden your experience across the full development cycle, ensuring continued professional and technical development.
Responsible for the inclusion of Cardiovascular elements into proposals.Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.Support preparation of customer and bid defense meetings, e.g. training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys Cardiovascular strategy.
Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
Clinical and market insight: Collect product performance and user feedback for R&D, MACA, and commercial teams to inform life cycle management, next-generation innovations, clinical study designs, and commercial strategies. Share insights, best practice, and data with national and regional MSL networks. Cross-functional collaboration and influence: Partner with internal cross-functional teams, including MACA, R&D, Regulatory, Marketing and national Market Access, to ensure integration of insights into our strategies.