Job Vacancies at Bioforum the Data Masters

Required skills:

• Minimum 8 years’ experience as a biostatistician working on clinical trials.
• Knowledge of advanced statistical methodology used in the analysis of clinical trial data
• In-depth knowledge of industry guidelines (GCP, ICH E9, regulatory guidelines)
• Study / Project lead / Customer interaction experience
• Attention to detail.
• Excellent communication skills.
• An Honours degree (a Masters degree / Ph.D will be an advantage) in a statistics related field.
• Experience interacting with a regulatory agency will be an advantage

Duties will include:

• Ownership of the statistical aspects and requirements on clinical trials done by Bioforum.
• Provide guidance on study designs and statistical methodology as appropriate.
• Interact with the customer and provide guidance / input on the statistical requirements and queries in the planning and during the conduct of the trial.
• Statistical review and preparation of documentation, including the statistics section of the study protocol, Statistical Analysis Plan, and statistical sections / results interpretation of Clinical Study Reports (CSRs).
• Provide training/mentorship to junior statisticians.
• Review Table, Listing and Figure (TLF) shells associated with the study SAP.
• Review ADaM and/or derived dataset specifications as required.
• Development of SAS programs for study TLFs focussing on efficacy and/or advanced statistical methodology.
• Review statistical output produced by the statistical programming team.
• Contribute to department wide initiatives to improve quality and efficiency.

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Required skills:

• Minimum 6 years’ experience as a biostatistician working on clinical trials.
• Knowledge of advanced statistical methodology used in the analysis of clinical trial data
• In-depth knowledge of industry guidelines (GCP, ICH E9, regulatory guidelines)
• Study / Project lead / Customer interaction experience
• Attention to detail.
• Excellent communication skills.
• An Honours degree (a Masters degree will be an advantage) in a statistics related field.

Duties will include:

• Ownership of the statistical aspects and requirements on clinical trials done by Bioforum.
• Provide guidance on study designs and statistical methodology as appropriate.
• Interact with the customer and provide guidance / input on the statistical requirements and queries in the planning and during the conduct of the trial.
• Statistical review and preparation of documentation, including the statistics section of the study protocol, Statistical Analysis Plan, and statistical sections / results interpretation of Clinical Study Reports (CSRs).
• Provide training/mentorship to junior statisticians.
• Review Table, Listing and Figure (TLF) shells associated with the study SAP.
• Review ADaM and/or derived dataset specifications as required.
• Development of SAS programs for study TLFs focussing on efficacy and/or advanced statistical methodology.
• Generate randomization schemes.
• Review statistical output produced by the statistical programming team.
• Contribute to department wide initiatives to improve quality and efficiency.

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Purpose:

Works alongside the VP: Biometrics to ensure successful performance of project deliverables. Department wide responsibilities across a team of statistical programmers driving performance, career development, team building and department initiatives.

Required skills:

• Minimum 12 years’ experience in a clinical research environment, of which at least 6 in statistical programming and at least 3 in a managerial capacity.
• In-depth knowledge of industry guidelines (GCP, ICH E9, regulatory guidelines).
• In-depth knowledge of CDISC standards (SDTM, ADaM).
• Project lead / Customer interaction experience.
• Proven ability to exceed customer satisfaction.
• Excellent communication skills.
• A Bachelor’s degree in a computer or life science discipline or equivalent experience and education

Duties may include:

• Lead a team of statistical programmers and managers in the consistent delivery of high quality and timely deliveries.
• Manage business development opportunities with support from the Senior Director/VP.
• Manage and oversee customer relationships of medium to large partnerships. Serves as escalation manager for large projects.
• Manage and oversee project management activities within a delivery team (scope, budget, resourcing, timelines).
• Line management of managers and/or statistical programmers, that includes maintaining a professional development plan for each line report.
• Manage and drive employee engagement across the department.
• Lead department-wide innovation projects and process improvement initiatives.
• Lead statistical programming activities including SDTM/ADaM dataset conversion, preparation of specifications, TLF programming, and review of data conventions / statistical output.

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Minimum requirements:

• Bachelor’s degree or above in a biomedical or science discipline and equivalent experience is required.
• Knowledge of data management processes.
• Microsoft Office and EDCs knowledge is required. 

Minimum experience:

• At least 4 years of experience in a clinical research environment

Minimum requirement/skills:

•  Knowledge of clinical trial process flow.
•  Microsoft Office and EDCs knowledge is required.

Minimum requirement/competencies:

•  English proficiency is required.

Responsibilities:

•  Overall and main responsibility of all DM activities for the assigned studies
•  Expertise in protocol and study conduct and ensure that the DM activities and deliverables meet the requirements within scope, budget and timelines
•  Supervise database development and quality data definitions and execution from study start up to database lock
•  Focal point of communication with sponsors
•  Build positive and collaborative relationships with Sponsors envisioning long term collaborations
•  Provide activates progress and status to VP DM and sponsor on ongoing basis as defined per study
•  Assign and allocate resources for all the required study activities
•  Supervise Data Operations Managers on database creation
•  Collaborate with Business Development and DM VP and to ensure the DM package offered for new proposals meet the study needs – including tailored made solutions and premium products as applicable
•  Supervise TMF completeness by Clinical Quality Control Associate and seek QA guidance as needed
•  Ensure study conduct is according to SOPs, WI and ICH GCP
•  Appraise the head of all relevant departments to obtain conformance/approval at all stages of the project
•  Supervise Data Review/Reconciliation/Coding and review Checklists to completeness of study activities on time
•  Lead creation of Validation and UAT scripts and execution
•  Collect all signatures required by sponsor prior to each milestones
•  Collaborates with QA and VP DM to address CAPAs as needed
•  Ability to work independently and manage company and sponsor’s stakeholders
•  Proven outstanding communication, problem solving and collaboration skills
•  Proven ability to meet or optimize timelines and budget cost effectiveness
•  Contribute to improve current processes following regulations
•  Update knowledge of DM processes
•  Mentor and knowledge sharing to other DM members

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Minimum requirements:

Bachelor’s degree or above in a biomedical or science discipline and equivalent experience is required.

Minimum experience:

At least 4 years of proven experience in a clinical research environment (Specifically data management field). 

Minimum requirement/skills:

• Knowledge of the clinical trial process flow
• Knowledge of data management principal, processes, and Electronic Data Capture (EDC) systems
• Knowledge of medical terminology, pharmacology, anatomy and/or physiology
• Knowledge of Good Clinical Practices and relevant regulatory guidelines

Minimum requirement/competencies:

• Proficient in English
• Ability to exercise excellent attention to detail
• Ability to take initiative and work independently
• Ability to establish and maintain effective working relationships with co-workers and managers
• Excellent interpersonal and communication skills, both verbal and written
• Strong problem-solving skills
• Good organizational, planning and time management skills (Administrative skills)
• Excellent computer skills
• Proficient in Microsoft Office products.

Responsibilities:

• Responsible for performing activities that are in compliance with applicable Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management
• Collaborate with Project Managers in study documents and deliveries, leading other data managers in the process
• Review study specific protocols and assist in the design of CRF utilizing company and/or sponsor data standards as applicable, collaborating with Project Managers and Head of Data Operations 
• Collaborate in Data Management Plan creation  
• Understand and comply with all applicable sections of Data Management Plan
• May lead the process in defining study specific Data Checks (automated and manual) 
• Leading/hands on study data review for a study including clinical database and external data according to Project Manager guidance and the study scope of work
• Lead data validation efforts prior to go live and as applicable during study
• Develop and maintain good communication and working relationships with CDM team
• Stand in as back-up to the Project Manager
• Responsible for resource planning on assigned projects
• Ensure clinical trial data completeness, integrity, and consistency 
• Oversight on DM activities meet the requirements set by scope of work and budget.
• Lead Quality Control procedures
• Ensure all study documents are saved under the relevant study files
• Supervise, Mentor and Train other Data management employees
• Contribute to departmental SOP development 
• Provide support on CDM Initiatives and Process improvements

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We currently have a position for a Senior Clinical Data Systems Designer (Technical designers/database architects). If you are looking fot the next step in your career and is interested in a more technical role, why not send your CV through to the Bioforum team? We are always looking for dynamic, quality driven people. 

Minimum requirements - qualifications: 

• Bachelor’s degree or above in a biomedical or science discipline and equivalent experience is required.

Minimum requirement - experience: 

• Working in a Technical designers/database architect role for at least 2-4 years.

Minimum requirement - skills: 

• Knowledge of clinical trial process flow.  Microsoft Office and EDCs knowledge is required.  (preferably RAVE or RAVEX) - 
• Basic knowledge of a programming language (eg: SQL/VBA/C# etc) will be beneficial.

Minimum requirement - competencies:

English proficiency is required

Responsibilities:

• Responsible for performing activities that follow applicable Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management.
• Oversight and/or execution of database design implementation and data validation checks programming (automated and manual) in various EDC systems in accordance with industry best practices and company/customer’s SOPs and standards as well as the management and updates surrounding any customer change requests.
• Provide support for investigation into identification of trends and troubleshooting of system related issues.
• Provide system specific support on Integrations, Custom Reporting and EDC modules.
• Perform setup of analytical reporting functionalities for study teams and/or customers.
• Assist and collaborate with Configuration specialist on system design and build considering company and/or customer standards.
• Provide support on Customer Program Level.
• Lead and/or provide support for any customer meetings as requested by the project manager.
• Collaborate with Project Managers and Configuration specialists in study related documentation e.g. Data Management Plan creation.
• Assist on data validation efforts prior to go live and as applicable during study.
• Potential hands-on study data review and/or validation including clinical database and external data reconciliation according to Project Manager guidance.
• Provide support in the development of guidance documents and associated processes for a system or specific tool.
• Knowledge of company level standards, SOPs, and processes to support reviews/updates and contribute to departmental SOP development.
• Supervise, mentor and train other Data management employees and team members.

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Purpose:

Works under the Director/Manager: Statistical Programming to provide lead statistical programming support and services for the statistical programming requirements on clinical projects.

Required skills:

• B.Sc degree in Life / Computer Science, Statistics, or equivalent.
• Minimum 5 years’ experience (2 years as Statistical Programmer Lead) working on statistical programming activities on clinical trials.
• In-depth knowledge of either SDTM and/or ADaM standards.
• Advanced knowledge of SAS, including SAS Macros.
• Demonstrated ability to program medium- to high complexity statistical output.
• Strong analytical and logical abilities.
• Excellent communication skills.

Duties will include:

• Leading statistical programming teams to deliver on projects.
• Interact with the customer and provide guidance / input on the statistical programmer requirements and queries during the conduct of the trial.
• Oversee quality and validation requirements of statistical output produced.
• Comply with CDISC standards where applicable.
• Review ADaM and/or derived dataset specifications as required.
• Program complex datasets / outputs.
• Contribute to department level initiatives to improve quality and efficiency.