Jobs at Thermo Fisher Scientific

As a Senior/Principal Biostatistician, you will function independently as Lead Statistician on projects, whilst leading/mentoring junior statisticians. Your responsibilities will include (but are not limited to) the following:

• Lead the project team, conduct team meetings, maintain project timelines, assess resources needed and allocate resources as required.
• Provide mentorship to junior team members.
• Develop statistical analysis plans, including analysis database and tables & listing specifications.
• Provide randomization schemes and appropriate documentation.
• Provide sample size calculations and review protocols for completeness, appropriateness of clinical design and sound statistical analysis.
• Coordinate and collaborate with Programmers and Data Management personnel as to database maintenance, updating and documentation.

To be considered for the role you should have the following qualifications and experience:

• Master's Degree in Biostatistics, Statistics, Mathematics or related field
• 5+ years of experience working in Biostatistics (previous CRO experience is desirable)
• Solid SAS programming experience (proficient in BASE, STAT, MACRO and GRAPH)
• Strong understanding of statistical principles and excellent statistical skills
• Good project management experience, demonstrated through previous experience managing multiple projects
• Capable of providing mentorship and promoting teamwork in a multi-disciplinary team setting
• Fluency in English is essential

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We are currently recruiting for an Early Development Services (EDS) Biostatistician to join the team based in EMEA. As a Biostatisitician you will;

• Develop statistical analysis plans, including tables & listing specifications
• Provide randomization schemes and appropriate documentation
• Provide sample size calculations and review protocols for completeness, appropriateness of clinical design and sound statistical analysis
• Coordinate and collaborate with Programmers and Data Management personnel as to database maintenance, updating and documentation.

To be considered for the role you should have the following qualifications and experience:

• Master's degree in statistics, biostatistics, mathematics or related field
• 2+ years of experience as a Biostatisitician, ideally working for a CRO
• Good SAS® programming skills and understanding of database structures
• Strong understanding of statistical principles and excellent statistical skills
• Good project management experience, demonstrated through previous experience managing multiple projects.

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Responsibilities include:

• Serve in a project lead role on selected multiple projects.
• Reviews and ensures adherence to departmental working practice documents and SOPs and contributes to their development.
• Increases knowledge base and professional skills of staff in areas including programming technology and techniques, clinical trials, and the pharmaceutical industry through on the job training, mentoring, and internal or external training courses.
• Works to increase the visibility of the company by encouraging the publications of articles in industry journals and presentations at conferences.
• Monitors and ensures adherence to contractual obligations or limits with our clients.
• Works directly with project team leaders and client representatives to assess and develop project goals and timelines.
• Provides general infrastructure support to the department. Examples include giving presentations at department meetings, contributing to documents or policies, contributing to and/or leading process improvement initiatives, and assisting with departmental web page development.
• MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and at least 6 years of experience that provides the knowledge, skills, and abilities to perform the job requirements, or Bachelor's degree in computer science, statistics, biostatistics, mathematics or related field or equivalent and relevant formal academic / vocational qualification, and at least 8 years of experience that provides the knowledge, skills, and abilities to perform the job requirements
• Preferred is at least 7 years of clinical trial experience as a statistical programmer and at least 2 years of leadership experience
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Advanced SAS programming skills and understanding of database structures.
• Solid experience in developing staff and their career objectives and the ability to motivate and inspire staff.
• Capable of facilitating communication with clients, project teams, departments and staff.
• Solid decision-making skills to decide company policies and procedures regarding programming.
• Solid understanding of tracking project budgets.
• Understand and participate in bidding programming work.
• Demonstrated leadership, motivation and problem-solving capability.
• Good understanding of clinical trials.
• Effective attention to detail.
• Capable of effectively organizing and managing multiple staff and assignments.
• Effective written and verbal communications skills, including proficiency in the English language.
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others and adjust to changing priorities.
• Proficiency in at least one programming language and strong technical programming sk

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Education and Experience:

• Master degree in statistics, biostatistics, mathematics or related field with 7+ years experience
• Extensive experience of statistics in a clinical trial environment.
• Extensive project lead/PM experience, clearly demonstrated in previous positions
• Evidence of providing expert statistical input in previous positions

Knowledge, Skills and Abilities:

• Mastery of the statistical principles underlying clinical trials
• Outstanding statistical skills
• Mastery of the regulatory issues associated with the reporting of clinical data in the submission process
• Excellent consultative skills
• Mastery of SAS® programming skills and familiarity of other statistical packages (eg StatXact, Nquery) and understanding of database structures
• Superb organizational, time management, and planning skills to create and follow timelines
• Capable of adapting and adjusting to changing priorities
• Excellent written and verbal communication skills, including proficiency in the English language
• Capable of working in a multi-disciplinary team setting
• Demonstrated initiative, motivation and problem solving skills
• Positive attitude and the ability to organise a team and work well with others

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The role coordinates all aspects of clinical activities on an international basis, including:

• Day to day management and leadership of a team of Clinical Operations members who are allocated to a project on a Country basis
• Responsibility for the achievement of the project clinical results within the contractual timelines and budget
• Development of clinical tools (e.g. Monitoring Plan and Guidelines) and set up of the required training, tracking and quality systems
• Work in partnership with the Project Manager to prepare, organize, and present at client meetings, including bid defense and kick off meetings
• Clinical Resource Management – provide input into preparation of forecast estimates of clinical results, assignments and identification of additional resource requirements
• Acting as a contact and support to the Sponsor for all clinical-related aspects of the study

Does this sound like you? If so, you need to have:

• Bachelor's degree or licensed certified health care training or equivalent combination of education and experience
• Previous cross-country CTM/ Project Management experience in excess of 2 year, including specific knowledge for Hematology/Oncology: early phase (Phase I HemOnc), immuno-oncology, pediatric HemOnc, rare disease, cohort/dose escalation experience, ovarian cancer
• Gene therapy experience would be considered as an advantage
• Clinical research experience in all phases of study life cycle, including start up, interim and close out
• Study finance management experience
• Ability and willingness to cross-region and in region travel according to the project needs
• Valid Passport and Driving Licence
• Be proficient in use of written and oral English language
• Knowledge, Skills and Abilities:
• Outstanding organizational skills
• Critical thinking skills
• Proven performance management abilities
• Excellent judgment and decision-making skills
• Highly effective verbal and written communication and presentation skills
• Expert knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
• The position is opened for all EMEA location for office or home-based employees.
• At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both expertly and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
• As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

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The role coordinates all aspects of clinical activities on an international basis, including:

• Day to day management and leadership of a team of Clinical Operations members who are allocated to a project on a Country basis
• Responsibility for the achievement of the project clinical deliverables within the contractual timelines and budget
• Development of clinical tools (e.g. Monitoring Plan and Guidelines) and set up of the required training, tracking and quality systems
• Work in partnership with the Project Manager to prepare, organize, and present at client meetings, including bid defense and kick off meetings
• Clinical Resource Management – provide input into preparation of forecast estimates of clinical deliverables, assignments and identification of additional resource requirements
• Acting as a contact and support to the Sponsor for all clinical-related aspects of the project

Does this sound like you? If so, you need to have:

• Bachelor's degree or licensed certified health care training or equivalent combination of education and experience
• Previous cross-country CTM/ Project Management experience in excess of 2 year, including specific knowledge for Neuroscience: CNS, Neurodegenerative diseases (Alzheimer’s disease, Parkinson’s disease), rare diseases (Duchenne muscular dystrophy, ALS, Fragile X), Ophthalmology, Psychiatry
• Gene therapy experience would be considered as an advantage
• Clinical research experience in all phases of study life cycle, including start up, interim and close out
• Study finance management experience
• Ability and willingness to cross-region and in region travel according to the project needs
• Valid Passport and Driving Licence
• Be proficient in use of written and oral English language

Knowledge, Skills and Abilities:

• Outstanding organizational skills
• Critical thinking skills
• Proven performance management abilities
• Excellent judgment and decision-making skills
• Highly effective verbal and written communication and presentation skills
• Experienced knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.

go to method of application »

The role coordinates all aspects of clinical activities on an international basis, including:

• Day to day management and leadership of a team of Clinical Operations members who are allocated to a project on a Country basis
• Responsibility for the achievement of the clinical deliverables within the contractual timelines and budget
• Development of clinical tools (e.g. Monitoring Plan and Guidelines) and set up of the required training, tracking and quality systems
• Work in partnership with the Project Manager to prepare, organize, and present at client meetings, including bid defense and kick off meetings
• Clinical Resource Management – provide input into preparation of forecast estimates of clinical deliverables, assignments and identification of additional resource requirements
• Acting as a contact and support to the Sponsor for all clinical-related aspects of the project

Does this sound like you? If so, you need to have:

• Bachelor's degree or licensed certified health care training or equivalent combination of education and experience
• Previous cross-country CTM/ Project Management experience in excess of 2 year, including specific knowledge for Infectious and Respiratory Diseases: Asthma, COPD, Idiopathic Pulmonary Fibrosis, PAH, Cystic Fibrosis, HIV, COVID-19
• Gene therapy experience would be considered as an advantage
• Clinical research experience in all phases of study life cycle, including start up, interim and close out
• Study finance management experience
• Ability and willingness to cross-region and in region travel according to the project needs
• Valid Passport and Driving Licence
• Be competent in use of written and oral English language

Knowledge, Skills and Abilities:

• Outstanding organizational skills
• Critical thinking skills
• Proven performance management abilities
• Excellent judgment and decision-making skills
• Highly effective verbal and written communication and presentation skills
• Experienced knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.

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Essential Functions:

• Performs programming tasks as assigned by study project team leads that includes but is not limited to independently creating, executing, maintaining, and validating programs that transfer data across multiple data management systems or operating systems, combining data from a variety of sources and structures, generating and storing summary data from a variety of sources, generating reports or combining multiple databases and validating programs that generate listings, tables and figures using SAS and standard tools and processes.
• Prepares and analyzes clinical trial patient datasets, such as laboratory data, vital signs data, tumor response data, imaging data, quality of life and well-being questionnaire data, or adverse events data, for clinical research purposes.
• Consults with researchers and multi-disciplinary project teams to analyze problems and recommend technology-based solutions and computational strategies for the specific project as assigned.
• Develops the customized codes to utilize existing tools and applications to provide the outputs or to validate outputs for clinical bioinformatics or technical use.
• Acts as the programming lead on studies of simple-moderate complexity to deliver on lead tasks/responsibilities.
• Actively seeks information to gain good understanding of the role of the lead programmer in the overall process and may act as the lead programmer on simple to moderately complex projects under close supervision.
• Ensures adherence to departmental working practice documents and SOPs, and contributes to the development informal training materials.
• Increases knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry by working closely with mentors, attending presentation / teaching events, and contributing to other general department documents and policies by assisting mentors with implementing best practice documents and articles.

Education and Experience:

• Master's degree in computer science, statistics, biostatistics, mathematics or related field and at least 1 year of experience that provides the knowledge, skills, and abilities to perform the job requirements

OR

• Bachelor's degree in computer science, statistics, biostatistics, mathematics or related field or equivalent and relevant formal academic / vocational qualification, and at least 3 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Firm understanding of one or more programming languages, including SAS
• Good attention to detail
• Good problem-solving skills
• Good written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English language
• Capable of effectively organizing and managing multiple assignments with challenging timelines
• Capable of adapting and adjusting to changing priorities
• Positive attitude and the ability to work well with others
• Demonstrated initiative and motivation
• Firm understanding of relational data base structure and complex data systems
• Capable of effectively capturing biostatistical metrics
• Capable of providing quality control support for statistical programming

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About The Role

The GCLP Quality Auditor assess medical laboratory activities to assure that GCLP and contractual obligations to client companies are met and determines whether clinical trial laboratory testing is conducted and reported in accordance with GCLP Guidelines, regulatory requirements, and relevant PPD and client procedural documents.

• Performs routine GCLP audits. Work assignments include multiple therapeutic indications across different projects and clients.
• Conducts a variety of client, internal, or GxP audits and supports regulatory inspections as requested by senior management
• Participates in process audits
• Performs other types of QA audits or activities (e.g., database audits, clinical study report audits, sample results tables, facility audits, process improvement)
• Serves as a resource to operational departments on audit or quality assurance subject matter
• Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings.

Education And Experience

• Bachelor’s degree in Medical Technology, or other related laboratory sciences. ASCP certification is an added advantage
• 2 - 3 years of Experience in Quality or compliance environment in a medical laboratory or pharmaceutical company and a previous experience in audit activities is an asset as well as the knowledge of the GCLP guidelines from DAIDS, BARQA and/or EMA/INS/GCP/532137/2010
• Experience in microbiology, hematology, and clinical chemistry
• Experience in GLP useful with a preference for GCLP, and/or CLIA.
• Working knowledge of Quality Assurance, GCLPs, or CLIA.
• 10 years’ experience with clinical laboratory operations, deliverables, and services (Laboratory Equipment/Instrumentation, Testing Facility Operations, Laboratory Information Systems, Laboratory Safety, Quality Management Systems, Records and Reports, Specimen Management and Tracking and Verification of Performance Specifications)
• Strong verbal and written skills in English. Individual with additional language skills in Thai/ Vietnamese will be highly considered.
• Great organizational skills
• Must be willing to travel internationally (post-pandemic) at 50-70% capacity. Local travel is expected during the pandemic.