Job Opportunities atThermo Fisher Scientific

• As a Programmer Analyst II within our FSP pillar, you will perform bioinformatics programming activities for the statistical and computational considerations of research projects in a client-dedicated capacity.

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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Key roles and responsibilities of a Clinical Research Physician are:

• Once trained, acting as principal investigator (PI) or sub-investigator ensuring ICH/GCP, and local regulations are met when conducting studies
• Conducting clinical studies in line with the protocol and to ensure the recruitment of eligible participants
• Review screening, pre-screening and screening success rates for clinical study delivery
• Providing information and support to consenting participants for a clinical study
• Responsible for checking participant inclusion/exclusion to studies
• Collaborating closely with and developing positive relations with sponsors, clients and clients’ contractors as required, projecting a conducive and courteous company image
• Carrying out clinical evaluation and clinical investigation of participants, ensuring protocol compliance, participant safety and quality data delivery
• Constantly seeking and suggesting quality improvements
• Taking ownership for ensuring serious adverse events / adverse events are reported appropriately

To be considered for this exciting opportunity you will need the following skills and experience:

• Medical degree (MBChB or equivalent)
• Registration with the Health Professions Council of SA (HPCSA)
• Ideally, previous experience within clinical research
• Have solid understanding of GCP (ICH/GCP and local regulations compliance, SA GCP)
• Valid medical malpractice insurance
• Demonstrate the inclination to provide practical help and mentorship to colleagues, providing practical solutions for any problems and supporting team development
• Show meticulous attention to detail in recording participant information and data, ensuring queries are acted upon in a timely and efficient manner to deliver quality of the highest standard
• Be a standout colleague, capable of building and sustaining positive relationships with colleagues, clients as well as study participants
• Fluency in local SA languages advantageous