Job Vacancies atLabcorp Drug Development

As an expert Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex clinical trials (phases I-III) for renowned, innovative and global top pharmaceutical companies. You will be responsible for all statistical programming deliverables of one or more complex clinical trials. 

This position allows you to participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas such as oncology, cardiovascular, respiratory, neurological, diabetes, rare diseases, pain, immunology etc. Your expertise as a Principal Statistical Programmer has a direct impact on improving the health and lives of thousands of patients around the globe every day.

Your responsibilities:

• Plan, execute and oversee all programming activities on a study, including but not limited to: resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
• Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform quality control reviews of SDTM, ADaMs and TFLs
• Produce and/or define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
• Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets, and contribute to the development of company and client standards
• Review SAPs and TFL shells from a programming perspective for studies, and advise on the development of complex TFL shells from a programming perspective
• Mentor less-experienced team members in best practices around SDTMs, ADaMs and TFLs while ensuring adherence to department practices and processes
• Present and share knowledge at department meetings
• Respond to QA and client audits and support qualification audits
• Contribute your expertise to proposal activities and bid defense
• Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming

Your profile:

• Degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
• In lieu of the above: an equivalent completed vocational training and / or equivalent professional experience in statistical programming for drug development
• Profound professional experience as a lead statistical programmer working on complex studies within a biotech, CRO or pharmaceutical company
• Knowledge in all aspects of clinical trials, from initial study set-up to study completion, with an excellent understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management
• Expert knowledge of base SAS, SAS macros, SAS/STAT and in debugging SAS programs
• Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards
• Solid experience with oncology and/or vaccine clinical trials and the corresponding datasets (safety and efficacy) and endpoints
• Excellent organizational, time management and project management skills with demonstrated leadership skills
• Outstanding problem solving and decision making skills, coupled with a proactive approach - anticipating issues and working to ensure they are avoided or resolved as quickly as possible
• An autonomous, collaborative work style, a curious mind and a keen attention to detail
• Business fluency in English – both verbal and written – is a must

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Description

• Biostatistician 2 required to work for Labcorp Drug Development supporting the Lead Biostatistician
• Opportunity to develop into a Lead Biostatistician and beyond
• Working with multiple Sponsors across several therapeutic areas in all phases of clinical trials
• This is a permanent full-time role, either office based or home based anywhere in Europe or in South Africa
• You must have some previous experience of working as a Biostatistician within clinical trials

Job Primary Functions

• Perform Lead Biostatistician role on simple studies, providing statistical oversight and attending relevant project meetings
• Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to line management and the project manager, as appropriate
• Preparation of Statistical Analysis Plans (including mock TFL shells) for simple and medium complexity studies under the supervision of senior statistical staff
• Perform statistical analysis for medium complexity studies
• Conduct overall statistical review of TFLs for medium complexity studies prior to client delivery
• Review CRF and other study specific specifications and plans
• May perform sample size calculation for Clinical Pharmacology studies under the supervision of senior statistical staff
• Provide statistical input and review of the CSR for simple studies
• Generation and review of randomization schedules from provided specifications under the supervision of senior statistical staff

Job Qualifications

• Master’s degree, equivalent, or higher in Biostatistics or related field
• Ability to program in one or more statistical software packages (SAS® preferred) used to conduct statistical analyses
• Ability to effectively communicate statistical concepts
• Interpersonal and effective communication skills
• Cooperative and team-oriented
• Self-motivation
• The ability to work to tight deadlines while maintaining high standards
• You must be fluent in English language (both verbal and written)

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In this role, you will:

• Assist and lead operations team alongside Senior CDM, develop project documentation, system setup, data validation processes and procedures assigned to junior staff. 
• As a lead data reviewer, you will perform all data operational tasks, ensuring quality standards are maintained.
• Work with Senior CDM to build study milestone timelines and be able to read and follow study timelines for on-time deliverables.
• Assist or lead internal and external DM meetings.
• Assist or lead to write, update/review and approve all required trial data documentation, including: Study-specific case report forms, CRF completion guidelines, DMP and Data Quality checks.
• Ensures study specific data transfer agreements are in place for all data vendors involved.
• Track scope changes and work with Senior CDM to ensure Sponsor approval is received and the scope change processed.
• Assist in the training of new staff on project specific DM processes.
• Coordinate with the DM study team to ensure all data related information is delivered within agreed timelines.
• Ensure all appropriate documentation and procedures are performed upon project completion for operations team.
• Attend client or internal audits as required and address client comments with the study team.
• Assist with the completion of Database Lock and Unlock activities with the Senior CDM.

Education

• University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
• Additional relevant work experience will be considered in lieu of formal qualifications.

Experience

• Experience in clinical data management as a Lead DM or Senior CDA or similar within early phase trials.
• Excellent oral and written communication and presentation skills.
• In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.