Job Opportunities at Thermo Fisher Scientific

• As a Biostatistics Sr. Manager, you will be responsible for the statistical aspects of clinical trials from design through analysis and reporting, including client or regulatory interactions. You will function as the lead statistician, project lead, or senior reviewer on complex or highly complex studies, whilst providing support and guidance to junior and senior team members. You will serve as a subject matter expert on statistical knowledge and clinical trial related topics. You will contribute to study proposals and bids, representing the department at bid defenses. In this position, you will oversee the resourcing of studies, develop, and implements strategies to ensure optimal efficiencies around process, programming, and schedule.

Essential Functions:

• Serves as (or mentors/coordinates staff in the roles of) lead statistician, project lead, senior reviewer, or project oversight on multiple projects, manages project team resources, budget, finance, timelines and ensures SOP compliance with appropriate documentation.
• Serves as (or mentors others in the role of) the randomization statistician on selected projects.
• Prepares and reviews statistical reports, (or mentors others in the role of) clinical study reports, integrated summaries of safety, integrated summaries of efficacy and other documents as required. Contributes statistical methods section for integrated clinical statistical reports. Reviews integrated clinical statistical reports.
• Manages resourcing and delivery strategy of complex books of work - ISS/ISE, submissions etc
• Aids departmental management in process-improvement strategies. Suggests, assesses, and provides leadership in the department for such initiatives. Conducts training and implementation of new procedures and new industry knowledge.
• Participates in strategic client franchise leadership.
• Provides mentorship and guidance to junior team members; assists people managers with leadership activities, such as interviewing, job description design, etc.

Education and Experience:

• Master degree in statistics, biostatistics, mathematics or related field with 8+ years experience

Knowledge, Skills and Abilities:

• Demonstrated initiative and motivation
• Capable of leading complex projects
• Effective management skills, as shown through the successful management of multiple projects and staff members, and proven ability to mentor and motivate staff
• Strong verbal and written communication skills
• Positive attitude and the ability to proactively direct and promote teamwork in a multi-disciplinary team setting
• In-depth knowledge of SAS® and clinical biostatistics
• In-depth understanding of the drug development process and FDA regulations
• Capable of managing change and uncertainty to optimize positive outcomes

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• As a Clinical Team Manager (CTM)/ Local Study Manager, you combine deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You take ownership, anticipate problems, find solutions and deliver results. You will be fully integrated into the client's SOPs and clinical systems.
• At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

• Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works independently on projects of moderate to high complexity and may assume regional lead or Clinical Study Manager responsibilities.

Essential Functions:

• Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.
• Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
• Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits(AFVs) and be accountable for project financials.
• Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
• May coordinate all start-up activities and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines.
• Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Oncology experience & vendor management, including CRO management
• Previous CTM experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).

Knowledge, Skills and Abilities:

• Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
• Strong planning and organizational skills to enable effective prioritization of workload and workload of team members
• Strong interpersonal and problem-solving skills to enable working in a multicultural matrix organization
• Solid understanding of change management principles
• Comprehensive understanding of the practices, processes, and requirements of clinical monitoring
• Strong judgment, decision making, escalation, and risk management skills
• Effective oral and written communication skills, including English language proficiency & the local language for countries outside the UK
• Capable of evaluating own and team members workload against project budget and adjust resources accordingly
• Strong financial acumen and knowledge of budgeting, forecasting and fiscal management
• Strong attention to detail
• In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
• Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
• Capable of independently managing clinical only studies

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Senior/Principal Biostatistician, FSP (Client-dedicated) - Home based, EMEA

• We are looking for Senior Biostatisticians who implement diverse statistical tasks supporting the clinical development programs. The tasks mainly focus on handling the statistical activities performed by the biometrics CRO and on guarantying by means of thorough review outstanding statistical quality. You will be involved throughout the full clinical trial process, from study design and protocol writing, over defining the statistical analyses (SAP) to reviewing all study outputs and the CSR.

Key Accountabilities/Responsibilities:

The senior Biostatistician is responsible for all clinical aspects for the assigned global clinical studies from preparation until archiving. The study responsibilities include:

• Serves as the responsible biostatistician on Phase I to III clinical trials. The trials can be relatively simple or complex.
• Contributes to clinical study synopses and protocols.
• Develops statistical analysis plans and/or performs senior review of statistical analysis plans.
• Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies.
• Provides relevant input in the development and review of CRFs.
• Performs lead review and sets up internal QC of TFLs.
• Performs critical review of derived datasets specifications and derived datasets (ADaM).
• Contributes to clinical study reports.
• Reviews simple to complex randomization specifications and dummy randomization schemes.
• Participates in bid defense meetings.
• Participates in meetings with diverse regulatory authorities (FDA, EMA, PEI).
• Contributes to press releases and scientific papers.

Desired Skills and Experience:

• Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices.
• Proficient with other statistical software such as R, EAST, Winbugs is a plus.
• Detailed knowledge of and experience with CDISC standards is desired.
• Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials.
• Displays excellent communication skills with proven leadership ability.
• Knowledge of ICH-GCP and other applicable legislation to successfully implement the clinical study.
• Master’s degree in statistics or biostatistics required.
• Minimum of 6-8 years of biostatistical experience desired.
• Experience in handling CROs and vendors is a plus
• Biotech experience is a plus
• Auto-immune and/or oncology clinical study background is a plus

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• As a Senior/Principal Programmer, you will act as the lead programmer, project lead, or project oversight lead on multiple projects for various clients, overseeing the statistical and bioinformatics programming aspects of clinical trials from design through analysis and reporting.

Your responsibilities will include (but are not limited to) the following:

• Acts as the lead programmer or project lead on studies of significant complexity, working directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and monitor study budgets.
• Assumes leadership responsibility as a contributing member of a multidisciplinary project team, communicating actively and frequently with other team members and ensuring adherence to working practice documents and SOPs.
• Independently creates, executes, maintains, and validates programs that transfer data across multiple data management systems or operating systems, combines data from a variety of sources and structures, generates and stores summary data from a variety of sources, generates reports or combines multiple databases and validates programs that generate listings, tables and figures using SAS.
• Manages and documents assignments to meet timelines and deliver high quality work, being familiar with any relevant contractual obligations or limits.
• Increases knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry.
• Provides training, guidance, and project leadership to junior team members.
• Provides general infrastructure support to the Department, including representing the company at industry conferences, presenting/teaching at department meetings, assisting in establishing training materials, and contributing to other general department documents or policies such as the development of departmental working practice documents and SOPs.
• Provides input into bidding process as requested.

Education and Experience:

• MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and at least 3-4 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 formal academic / vocational qualification, and at least 5-6 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.

Knowledge, Skills and Abilities:

• In-depth understanding of one or more programming languages
• Strong attention to detail
• Strong problem solving and innovative skills
• Strong written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English language
• Capable of independently and effectively organizing and managing multiple assignments with challenging timelines
• Capable of adapting and adjusting to changing priorities
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
• Demonstrated leadership, initiative and motivation
• In-depth understanding of relational data base structure and complex data systems
• Capable of training and mentoring others
• Demonstrated leadership ability and ability to work on a multi-disciplinary project team
• Solid project management skills to act as project lead across the most challenging and complex projects
• Capable of effectively capturing biostatistical metrics
• Capable of providing quality control review for statistical programming and identifying solutions and process improvements.