Biostatistician

Founded in 1997, Ergomed is a global provider of high-quality services to the biopharmaceutical industry, spanning all phases of clinical trials, post-approval pharmacovigilance, and medical information. Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, and Ergomed Clinical Research, a complete, global Phase I-IV clinical development and trial management services with a strong heritage in the development of drugs in rare diseases and oncology.• 1,400+ highly qualified professionals• Global full-service CRO• 25+ years of experience• Therapeutic specialization in oncology• Strong expertise in rare disease trials• Robust clinical safety system• Choice of leading drug safety databasesOur key services include:• Clinical Research Services• Pharmacovigilance• Medical Information• Regulatory• Medical Writing• Site Management• Study Physician Support• Biostatistics• Patient Study Support

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We partner with small to midsize biotech companies to move promising therapies through early phase development. The Principal Biostatistician will be part of a collaborative team that works with the sponsor, PM, clinical team, data managers, medical writers, statistical programmers, and potentially many other team members to support the statistical needs of the assigned clinical study(ies). Responsibilities include maintaining oversight of all contracted statistical output and activities, acting as the study lead for multiple studies, and providing mentoring and support to junior statisticians.

The Principal Biostatistician is responsible for the design, analysis, and interpretation of clinical studies as a lead or contributing team member.

Principal Biostatistician

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We partner with small to midsize biotech companies to move promising therapies through early phase development. The Principal Biostatistician will be part of a collaborative team that works with the sponsor, PM, clinical team, data managers, medical writers, statistical programmers, and potentially many other team members to support the statistical needs of the assigned clinical study(ies). Responsibilities include maintaining oversight of all contracted statistical output and activities, acting as the study lead for multiple studies, and providing mentoring and support to junior statisticians.Requirements:<ul><li> Master’s degree (or Higher) in biostatistics, statistics, mathematics or other related disciplines.</li><li> General understanding and application of biostatistics in clinical trials.</li><li> Strong previous related experience working in a Contract Research Organization.</li><li> Communication skills.</li><li> Presentation skills.</li><li> Knowledge of the MS Office Suite.</li><li> Proficiency in one or more statistical programming language (SAS Preferred).</li><li> Collaboration across cross-functional teams.</li><li> Good understanding of ICH and regulatory landscape.</li><li> Knowledge of advanced statistical methods (e.g., survival analysis, logistic regression, and mixed models).</li><li> Fluency in English.</li></ul>Benefits:<ul><li> Work-life balance</li><li> Collaborative team environment</li><li> Opportunity to make an impact in clinical research</li></ul>

Ergomed

Principal Biostatistician The Principal Biostatistician is responsible for the design, analysis, and interpretation of clinical studies as a lead or contributing team member. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We partner with small to midsize biotech companies to move promising therapies through early phase development. The Principal Biostatistician will be part of a collaborative team that works with the sponsor, PM, clinical team, data managers, medical writers, statistical programmers, and potentially many other team members to support the statistical needs of the assigned clinical study(ies). Responsibilities include maintaining oversight of all contracted statistical output and activities, acting as the study lead for multiple studies, and providing mentoring and support to junior statisticians. Biostatistician Analyst Ergomed medical-practices clinical-research pharmaceutical-manufacturing medical-equipment-manufacturing medical-and-diagnostic-laboratories research-services medical-services allergy biotechnology clinical-safety clinical-trials contract-research-organization covid-19 cro drug-development medical-information metabolic-diseases neurology oncology orphan-drugs pharmaceuticals pharmacovigilance rare-diseases respiratory-diseases

As a Principal Biostatistician, you will lead the design and analysis of clinical studies, collaborating with various teams to support statistical needs. This role involves oversight of statistical outputs and mentoring junior statisticians.

Study Start Up Specialist

Study Start Up Specialist coordinates and oversees all activities related to achieving the goal of site activations in accordance with the contract, trial protocol and other study specific requirements, ICH-GCP, all applicable SOPs and regulatory requirements. Study Start Up Specialist takes leadership and acts as the primary point of contact for Sponsor and internal stakeholders during the study start-up process. Assume leadership during study Set-up process ensuring development of start up strategy, effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates. Serve as main point of contact for all project-specific Study Start-Up activities. Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures. Prepare, collect, review regulatory information to support regulatory submissions for initial authorization and maintenance, in compliance with all applicable regulations. Collect, review for completeness and compliance, and track essential documents for Study Start-Up to facilitate efficient site initiation and activation. Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information. Prepare study team reports or updates regarding status of essential document collection, review and approval. Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development on site level (if applicable) and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submissions/approvals. Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation and site initiation. Take ownership in contract negotiations with investigative sites or coordinate other team members assigned to perform contract negotiations as per study specific RACI. Assist with feasibility and site identification activities as needed. Arrange for and/or review translation of essential documents as required. Attend project team meetings and training sessions according to project and/or Sponsor requirements. Ensure all relevant documents are submitted to Trial Master File (TMF) for filing as per study specific guidance. Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS. Support, mentor and train department staff and new-hires. Provide support to proposal development and input to budgets, provide department representation to BD meetings as required. Assist with development and implementation of trainings and SOPS/practice improvements.

The Study Start Up Specialist coordinates and oversees all activities related to achieving the goal of site activations in accordance with the contract and regulatory requirements.

Study Start Up Specialist coordinates and oversees all activities related to achieving the goal of site activations in accordance with the contract, trial protocol and other study specific requirements, ICH-GCP, all applicable SOPs and regulatory requirements. Study Start Up Specialist takes leadership and acts as the primary point of contact for Sponsor and internal stakeholders during the study start-up process. Assume leadership during study Set-up process ensuring development of start up strategy, effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates. Serve as main point of contact for all project-specific Study Start-Up activities. Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures. Prepare, collect, review regulatory information to support regulatory submissions for initial authorization and maintenance, in compliance with all applicable regulations. Collect, review for completeness and compliance, and track essential documents for Study Start-Up to facilitate efficient site initiation and activation. Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information. Prepare study team reports or updates regarding status of essential document collection, review and approval. Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development on site level (if applicable) and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submissions/approvals. Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation and site initiation. Take ownership in contract negotiations with investigative sites or coordinate other team members assigned to perform contract negotiations as per study specific RACI. Assist with feasibility and site identification activities as needed. Arrange for and/or review translation of essential documents as required. Attend project team meetings and training sessions according to project and/or Sponsor requirements. Ensure all relevant documents are submitted to Trial Master File (TMF) for filing as per study specific guidance. Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS. Support, mentor and train department staff and new-hires. Provide support to proposal development and input to budgets, provide department representation to BD meetings as required. Assist with development and implementation of trainings and SOPS/practice improvements.Requirements:<ul><li> Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience</li><li> Minimum 5 years within pharmaceutical/CRO industry</li><li> Proven ability to successfully manage multi-country projects in start-up</li><li> Excellent organizational and management skills</li><li> Strong planning, strategizing, managing, progress monitoring, scheduling, problem-solving and critiquing skills</li><li> Good interpersonal skills in a fast-paced, deadline oriented, and changing environment</li><li> Excellent self-motivation and motivation skills</li><li> Outstanding knowledge of ICH GCP across all areas</li></ul>Benefits:<ul><li> Training and career development opportunities internally</li><li> Strong emphasis on personal and professional growth</li><li> Friendly, supportive working environment</li><li> Opportunity to work with colleagues based all over the world, with English as the company language</li></ul>

Study Start Up Specialist The Study Start Up Specialist coordinates and oversees all activities related to achieving the goal of site activations in accordance with the contract and regulatory requirements. Study Start Up Specialist coordinates and oversees all activities related to achieving the goal of site activations in accordance with the contract, trial protocol and other study specific requirements, ICH-GCP, all applicable SOPs and regulatory requirements. Study Start Up Specialist takes leadership and acts as the primary point of contact for Sponsor and internal stakeholders during the study start-up process. Assume leadership during study Set-up process ensuring development of start up strategy, effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates. Serve as main point of contact for all project-specific Study Start-Up activities. Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures. Prepare, collect, review regulatory information to support regulatory submissions for initial authorization and maintenance, in compliance with all applicable regulations. Collect, review for completeness and compliance, and track essential documents for Study Start-Up to facilitate efficient site initiation and activation. Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information. Prepare study team reports or updates regarding status of essential document collection, review and approval. Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development on site level (if applicable) and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submissions/approvals. Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation and site initiation. Take ownership in contract negotiations with investigative sites or coordinate other team members assigned to perform contract negotiations as per study specific RACI. Assist with feasibility and site identification activities as needed. Arrange for and/or review translation of essential documents as required. Attend project team meetings and training sessions according to project and/or Sponsor requirements. Ensure all relevant documents are submitted to Trial Master File (TMF) for filing as per study specific guidance. Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS. Support, mentor and train department staff and new-hires. Provide support to proposal development and input to budgets, provide department representation to BD meetings as required. Assist with development and implementation of trainings and SOPS/practice improvements. Study Start Up Specialist Operations Ergomed medical-practices clinical-research pharmaceutical-manufacturing medical-equipment-manufacturing medical-and-diagnostic-laboratories research-services medical-services allergy biotechnology clinical-safety clinical-trials contract-research-organization covid-19 cro drug-development medical-information metabolic-diseases neurology oncology orphan-drugs pharmaceuticals pharmacovigilance rare-diseases respiratory-diseases

As a Study Start Up Specialist, you will lead the study start-up process, ensuring compliance with protocols and regulations while serving as the primary contact for stakeholders. You will manage regulatory deliverables and facilitate site activations effectively.

Analyst

The job postings include various roles related to benefit/risk assessment, pharmacovigilance, and client quality management across multiple international locations. The positions involve monitoring drug safety, managing pharmacovigilance systems, and ensuring compliance with regulatory standards. The company is a global drug safety organization committed to making a lifesaving difference, offering opportunities in diverse locations such as Japan, Germany, Spain, Italy, the UK, and more.

Multiple Benefit/Risk Officer positions available across various European cities, focusing on drug safety and pharmacovigilance.

Benefit/Risk Officer

The job postings include various roles related to benefit/risk assessment, pharmacovigilance, and client quality management across multiple international locations. The positions involve monitoring drug safety, managing pharmacovigilance systems, and ensuring compliance with regulatory standards. The company is a global drug safety organization committed to making a lifesaving difference, offering opportunities in diverse locations such as Japan, Germany, Spain, Italy, the UK, and more.Requirements:<ul><li> Experience in pharmacovigilance or drug safety preferred</li><li> Knowledge of clinical trials and HCP interactions beneficial</li><li> Language skills in Japanese for some roles</li><li> Ability to work in a team environment</li><li> Strong attention to detail and analytical skills</li></ul>Benefits:<ul><li> Opportunities to work in multiple international locations</li><li> Supportive team environment</li><li> Career development in pharmacovigilance and drug safety</li><li> Possibility of remote or hybrid work depending on location</li></ul>

Benefit/Risk Officer Multiple Benefit/Risk Officer positions available across various European cities, focusing on drug safety and pharmacovigilance. The job postings include various roles related to benefit/risk assessment, pharmacovigilance, and client quality management across multiple international locations. The positions involve monitoring drug safety, managing pharmacovigilance systems, and ensuring compliance with regulatory standards. The company is a global drug safety organization committed to making a lifesaving difference, offering opportunities in diverse locations such as Japan, Germany, Spain, Italy, the UK, and more. Analyst IT Support Ergomed medical-practices clinical-research pharmaceutical-manufacturing medical-equipment-manufacturing medical-and-diagnostic-laboratories research-services medical-services allergy biotechnology clinical-safety clinical-trials contract-research-organization covid-19 cro drug-development medical-information metabolic-diseases neurology oncology orphan-drugs pharmaceuticals pharmacovigilance rare-diseases respiratory-diseases

The company is hiring Benefit/Risk Officers in cities like Prague, Lisbon, Bucharest, Sarajevo, and Sofia to support pharmacovigilance activities. Additional roles include client quality managers and pharmacovigilance project managers in multiple countries.

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