Job Opportunities at Thermo Fisher Scientific

• As an Associate Manager Sites, for our dedicated Synexus research site at Helderberg, Somerset West, you will manage the day-to-day activities and performances including growth, delivery of targets at a dedicated research site. You will be responsible for the site staff management, quality management as well as the appropriate planning and coordination of resources and facilities.

Essential Functions and Other Job Information:

• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counselling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
• Coordinates site activities to ensure the delivery of targets.
• Communicates targets to the site teams, ensuring they are aware of expectations, and monitors progress.
• Oversees the planning and coordination of patient recruitment activities, patient bookings and schedule management, ensuring efficiency and that resources are used to capacity.
• Liaises with senior management to control costs and budgets and implement cost saving initiatives.
• Holds regular site meetings and clearly communicates study and protocol requirement as well as business goals.
• Ensures compliance with the company quality framework, regulatory (GCO) legislation, guidelines and international standards (Global/Local COPS/SOPS).
• Ensures the implementation of quality control methods, practices and improvements and that risks are highlighted to the compliance department.
• Ensures the site and facilities provide a safe working environment and is H&S compliant.
• Leads the site team towards the delivery of the business objectives and supports their growth and performance.

Knowledge, Skills and Abilities:

• Thorough knowledge of clinical trial processes and expertise / knowledge of clinical study operations
• Good understanding of FDA regulations and ICH GCP guidelines
• Good understanding of budgeting / forecasting / planning projects
• Proven leadership skills
• Good time management skills and ability to work on multiple projects simultaneously
• Good problem solving and troubleshooting abilities
• Proficient in Microsoft Office products
• Capable of acting as a liaison with the client, investigator, study team and other departments/divisions

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• As a Senior Biostatistician within our Early Phase team, you will function independently as a project lead or lead statistician to deliver the project tasks/responsibilities. As well you will perform project management functions relating to the administrative and scientific activities of specific project work and team members.

Essential Functions:

• Ensures compliance with the activities outlined in the department's Working Practice Documents and contributes changes as needed. Follows departmental procedures for statistical analyses and programming work.
• Work independently as a project lead or as lead statistician to deliver on lead tasks/responsibilities across large and complex projects. Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.
• Provides sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contributes to writing appropriate protocol sections. Provides randomization schemes and appropriate documentation.
• Writes / reviews analysis plans and guide others on the team in its implementation. Defines appropriate methods and procedures for statistical analysis.
• Provides specifications for analysis database, oversee its development, and assures completeness for use in all programming. Coordinates with programmers and data management personnel as to database maintenance, updating, and documentation. Performs statistical analysis for key efficacy endpoints.
• Prepares reports, manuscripts, and other documents. Contributes statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents.
• Monitors project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope. Communicates with sponsors concerning project work scope and budgetary changes after reviewing with management.
• Mentors members of the department by providing project guidance and statistical advice and by promoting employee development, completing performance planning, and providing resource planning.
• Provides general infrastructure support to the Department (presents / teaches at the department meetings, contributes to other general department documents or policies, assists with newsletter, helps in department libraries, or trains new hires).
• Acts as the representative of the department to other divisions. Assists in bidding and business development activities. Consults with business development with respect to bids and timelines.

Education and Experience:

• Master's degree in statistics, biostatistics, mathematics or related field.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’).

Knowledge, Skills and Abilities:

• Strong SAS® programming skills
• (Proficient in BASE, STAT, MACRO and GRAPH) and understanding of database structures
• Capable of directing and promoting teamwork in a multi-disciplinary team setting
• Strong understanding of statistical principles and strong statistical skills
• Solid project management skills, as shown through management of multiple projects
• Demonstrated initiative and motivation
• Strong written and verbal communications skills, including proficiency in the English language
• Strong organizational, time management, and planning skills to create and follow timelines, conduct long- range planning, adapt to changing priorities and handle multiple projects
• Strong interpersonal skills and positive attitude to work effectively in a team environment and act as a liaison with other department.

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• As an Associate Programming Director, you will provide project leadership to a team of senior staff within the department who are responsible for all bioinformatics programming aspects of clinical trials.

Essential Functions:

• Supports people managers with interviewing and selection, job description preparation, professional development, goal setting and performance management. May support people managers through input on behavioral and technical coaching and mentoring, employee counseling and separations. Advises on courses of action on salary administration, hiring, corrective action and terminations. Promotes all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good scientific, ethical and regulatory standards.
• Reviews, approves changes to and ensures adherence to departmental Working Practice Documents and SOPs, and contributes changes as needed.
• Recommends strategies to senior management on ways to increase the 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.
• Ensures senior management is informed of team activities, accomplishments and needs.
• Manages resource planning and utilization rate for the department. Ensures that appropriate personnel resources are applied to projects based on global priorities and relative complexity.
• Liaises with other departments within the company and the client.
• Participates in divisional decision making, bid preparation and marketing activities.
• Provides project oversight role and consultation for team's projects.
• Reviews and/or approves documents related to project activities.
• Provides general infrastructure support to the department. Examples include giving presentations at department meetings, and contributing to documents or policies, coordinating process improvement, and implementing programming standards.

Education and Experience:

• MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and at least 8 years of experience that provides the knowledge, skills, and abilities to perform the job requirements, or Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years).

Knowledge, Skills and Abilities:

• Mastery of SAS programming skills and understanding of database structures
• Capable of effectively mentoring senior staff and promote teamwork in a multi-disciplinary team setting
• Effective leadership skills, as shown through management of multiple projects and proven ability to mentor and motivate staff
• Demonstrated initiative and motivation
• Excellent written and verbal communications skills
• Positive attitude and the ability to work well with others
• Capable of delegating tasks and facilitating the completion of assignments
• Capable of driving innovation in developing new ideas related to process improvements
• Comprehensive organizational, judgment, analytical, decision-making and interpersonal skills
• Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverables