Jobs at Covance

Job Overview

• Principal Statistical Programmer required to work for Covance
• You will be employed by Covance working in our late phase (II-IV) full-service group with the opportunity to work across several therapeutic areas
• Home based anywhere in Europe or South Africa
• You must have previous experience of working as a Lead Statistical Programmer in either a biotech, CRO or pharma company using the SAS programming language
• Candidates must be fluent in English language (both verbal and written)

Join our growing team and discover your extraordinary potential by working as a Covance Principal Statistical Programmer. As a Principal Statistical Programmer at Covance you will be responsible for all statistical programming deliverables of one or more complex clinical trials. You will work in our internal late phase full service group so you will enjoy a varied role working for different sponsors across several therapeutic areas within phases II-IV. The position offers a strong support network, flexible working solutions and the opportunity to progress your career. If you are an experienced Lead Statistical Programmer and you are looking for your next career move then this is a fantastic opportunity. This really is an incredibly exciting time to be joining Covance as we continue to grow and expand. This is a permanent, full-time office or home-based role anywhere within Europe or South Africa.

Job Primary Functions

• Perform the role of the Lead Statistical Programmer.
• 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 QC of SDTM, ADaMs and TFLs
• Produce 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 Covance 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-experience programmers in the processes around SDTMs, ADaMs and TFLs 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 to proposal activities and participate in bid defenses meetings in order to win new business
• Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming

Education/Qualifications:Experience:

• BSc, preferably in computing, life science, mathematical or statistical subject
• You must have previous experience of working as a Lead S tatistical Programmer on complex studies in either a biotech, CRO or pharma company using SAS
• 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.
• Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards
• Excellent organizational, time management and project management skills with team leadership experience, as demonstrated by ability to organize and motivate project teams and the ability to delegate and prioritize work to meet project timelines
• Self motivation and ability to work independently without appreciable direction
• Ability to apply extensive technical expertise and the full knowledge of other related disciplines to provide consultancy and advice on programming and wider related issues to other departments and disciplines
• Excellent problem solving skills, a proactive approach, anticipating issues and working to ensure they are avoided or resolved as quickly as possible
• A willingness to make decisions seeking advice from statistical programming managers or directors to confirm decisions when necessary
• A proactive approach to developing and maintaining effective working relationships with staff in other disciplines, often in other locations and in working to achieve consistent processes and standards across them
• Candidates must be fluent in English language (both verbal and written)

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Job Overview

• Statistical Programmer 2 required to work for Covance
• Excellent opportunities to progress
• Varied, fast paced environment
• Office based in Leeds, Yorkshire, UK or work from home anywhere in Europe or South Africa
• Candidates must have experience of working as a Statistical Programmer within clinical research

Join our growing team and discover your extraordinary potential by working as a Covance Statistical Programmer 2 within our Early Phase statistical programming department. As a Level 2 Statistical Programmer at Covance you will be responsible for providing SAS programming support in terms of SDTM and ADaM datasets and tables, figures and listings (TFLs) for reports. Once trained in Covance systems and processes you will also assume the role of Lead Programmer for allocated studies.

Working within early phase statistical programming we offer, in a word, variety…

In the type of studies: PK, Bioequivalence, Metabolism, Dose Escalation etc. and Sponsors

• In Early Phase we are not assigned for years to the same study, so you will be exposed to multiple studies for clients with different needs as well as working with talented internal colleagues
   

Job Primary Functions

• With sufficient experience assume the role of a Lead Statistical Programmer with support from senior programming staff.
  • 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 SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
• Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs and Reviewers Guides to support SDTMs and ADaMs
• With support from senior programming staff, develop specifications for SDTMs and ADaM datasets
• Review SAPs and TFL shells from a programming perspective for studies with support from senior programming staff
• Respond to QA and client audits with support from senior programming staff
   

Education/Qualifications

A comprehensive full job description is available.

• BSc, preferably in computing, life science, mathematical or statistical subject

Experience:

• Candidates must have experience of working as a Statistical Programmer within a healthcare company within Europe or South Africa and have some exposure to Leading studies
• Knowledge of CDISC requirements
• Positive attitude and willingness to learn and contribute in a team setting and communicate effectively within the team environment
• Good organization skills and the ability to prioritize own work
• Self motivation and ability to work independently
• A cooperative and team-oriented approach
• You must be fluent in English language (both verbal and written).

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In This Role, You Will

• Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.
• Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
• Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
• Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
• Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specifications.
• Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions.
• Coordinate the development and testing of data management systems edit / data validation checks) diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
• Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
• Advanced planning and risk management for projects (issue escalation, resource management).
• Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
• Assist with goal creation and performance review assessment for data review project staff.
• Maintain technical data management competencies via participation in internal and external training seminars.
• Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.
• Identify areas for process and efficiency improvement and implement solutions on assigned projects.
• Support achievement of project revenue and operating margin for data management activities to agreed targets.
• Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary.
• Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
• Review literature and research technologies/procedures for improving global data management practices.
• Perform other duties as assigned by manager

Education/Qualifications:

• 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.
• Broad knowledge of drug development processes.
• Understanding of global clinical development budgets and relationship to productivity targets.
• Knowledge of effective clinical data management practices.
• Knowledge of time and cost estimate development and pricing strategies.
• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.

Experience:

• Previous years relevant work experience in data management with technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
• Demonstrated skill for technical management of staff exceeding 5 employees.
• Financial management of gross revenues in excess of $250K per year.
• 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.
• Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
• Demonstrated managerial and interpersonal skills

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Extensive Knowledge Of

• Drug development process and client needs.
• ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.

Experience:

• Relevant experience as a line manager
• Relevant clinical research experience in a pharmaceutical company or CRO
• Site Management Monitoring experience in South Africa: monitoring international clinical studies
• Thorough knowledge of drug development process and thorough knowledge of relevant SOPs, ICH, and GCP guidelines
• Proficiency with on site monitoring activities
• Ability to resolve project-related problems and prioritize workload for self and team

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Are you a self-starter who knows how to take initiative in your daily work? Would you enjoy making a real difference in the lives of others.

If you are looking for a high-energy position in a collaborative environment, learn more about the Lead Data Manager opportunity with Covance.

In This Role, You Will

• Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.
• Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
• Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
• Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
• Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specifications.
• Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions.
• Coordinate the development and testing of data management systems edit / data validation checks) diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
• Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
• Advanced planning and risk management for projects (issue escalation, resource management).
• Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
• Assist with goal creation and performance review assessment for data review project staff.
• Maintain technical data management competencies via participation in internal and external training seminars.
• Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.
• Identify areas for process and efficiency improvement and implement solutions on assigned projects.
• Support achievement of project revenue and operating margin for data management activities to agreed targets.
• Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary.
• Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
• Review literature and research technologies/procedures for improving global data management practices.
• Perform other duties as assigned by manager

Education/Qualifications:

• 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.
• Broad knowledge of drug development processes.
• Understanding of global clinical development budgets and relationship to productivity targets.
• Knowledge of effective clinical data management practices.
• Knowledge of time and cost estimate development and pricing strategies.
• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.

Experience:

• Previous years relevant work experience in data management with technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
• Demonstrated skill for technical management of staff exceeding 5 employees.
• Financial management of gross revenues in excess of $250K per year.
• 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.
• Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
• Demonstrated managerial and interpersonal skills

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Job Overview

• Senior Statistical Programmer required to work for Covance within Early Phase
• Excellent opportunities to progress
• Varied, fast paced environment
• Office based in any European or South African offices or work from home anywhere in Europe or South Africa
• Candidates must have experience of working as a Lead Statistical Programmer within a healthcare company within Europe or South Africa

Join our growing team and discover your extraordinary potential by working as a Covance Senior Statistical Programmer within our Early Phase statistical programming department. As a Senior Statistical Programmer at Covance you will assume the role of Lead Programmer for allocated studies, developing and maintaining SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs.

Working within early phase statistical programming we offer, in a word, variety…

In the type of studies: PK, Bioequivalence, Metabolism, Dose Escalation etc. and Sponsors

• In Early Phase we are not assigned for years to the same study, so you will be exposed to multiple studies for clients with different needs as well as working with talented internal colleagues

Job Primary Functions

• Perform the role of the Lead Statistical Programmer
• 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 SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
• Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and Reviewers Guides to support SDTMs and ADaMs
• Develop specifications for SDTMs and ADaM datasets
• Review SAPs and TFL shells from a programming perspective for studies
• Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs
• Present and share knowledge at department meetings
• Respond to QA and client audits, and support qualification audits
• Identify processes within programming that will increase productivity, quality and efficiency

Education/Qualifications:Experience:

• BSc, preferably in computing, life science, mathematical or statistical subject
• Candidates must have experience of working as a Lead Statistical Programmer within a healthcare company within Europe or South Africa
• Show evidence of and experience of leading studies and experience in study set-up and review of study specific documents.
• Knowledge of CDISC requirements
• Positive attitude and willingness to learn and contribute in a team setting and communicate effectively within the team environment
• Good organization skills and the ability to prioritize own work
• Self motivation and ability to work independently
• A cooperative and team-oriented approach
• You must be fluent in English language (both verbal and written)

go to method of application »

Data Management leadership for all aspects of the data management process to include responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. Also assume responsibility for all data management activities leading to database lock according to Client quality expectations within project timelines and budgets.

Lead data focused project team meetings, meeting frequently with the study leads of Electronic Data Capture (EDC) Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned, coordinated interdepartmentally, and proactively identifying potential risks and mitigations, and effectively communicating data-driven discussions in order to achieve database lock dates with the highest possible data quality.

Essential Job Duties

• Lead study Data Manager for studies which are medium complexity including but not limited to - combination of healthy and patient populations, multi-site, medium complexity in protocol design or client management requirements.
• As the study data lead; be accountable for all DM deliverables per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest delivery quality, while adjusting resource allocations accordingly.
• Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
• Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary including at study initiation meetings.
• Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of EDC Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager apprised of project progress.
• Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on Data Management resources or deliverables and consult with Project Manager and/or functional group management as necessary.
• Keep Project Manager, Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. work scope changes, timeline impacts).
• Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate in order to meet timelines for deliverables. Ensure all appropriate documentation and procedures are performed upon project completion.
• Ensures study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study.
• Develop and maintain client relationships and review client satisfaction surveys. Implement appropriate action plans including driving process improvements and team training.
• Applies corrective interventions where necessary to maintain project budget compliance and profit expectations. Track scope changes and work with the Clinical Pharmacology Project Manager to ensure that Sponsor approval is received and the scope change processed.
• Provides leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations.
• Ensures service and quality meet agreed upon specifications per the DMP and scope of work.
• Have input in writing, reviewing and updating SOPs and associated documents as required.
• Performs QC on all aspects of work performed in DM to ensure that data quality and integrity is maintained. Feedback constructively on relevant issues and initiate process review as appropriate.
• Maintain accurate records of all work undertaken.
• Perform quality control on all aspects of the study as appropriate to include, but not be limited to: all study documentation, query generation and integration; to ensure that internal and client quality standards are achieved.
• Perform reconciliation of the clinical database against safety data, laboratory data or any other third party data as appropriate. Utilise local laboratory systems and batch data load facilities where appropriate.
• Perform medical and medication coding.
• Oversee the performance of the Data Management Study team to ensure that client satisfaction is achieved through delivery of quality data, on-time and on-budget. Arrange internal or external meetings as appropriate.
• Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.
• Actively promote Biometrics services to sponsors whenever possible.
• Performs other related duties as assigned by management.

Education/Qualifications

• 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).
• Knowledge of drug development process.
• Knowledge of effective clinical data management practices.
• Fluent in English, both written and verbal.
• In lieu of above requirement, approximately six years experience in related field (e.g. pharmaceutical, laboratory, data analysis).

Preferred

• Knowledge of Covance and the overall structure of the organization.
• Knowledge of Covance standard operating procedures.

Experience

• Six years of combined early or late stage DM experience in DM with two years of direct sponsor management and two years of technical mentoring experience.
• Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets.
• Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
• Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives and to encourage team members to seek solutions.
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.
• Time management skill and ability to adhere to project productivity metrics and timelines.
• Ability to work in a team environment and collaborate with peers.
• Good organizational ability, communication and interpersonal skills.
• Team working skills and good collaborator skills.
• Constructive problem solving attitude while deadline focused with time demands, incomplete information or unexpected events.
• Knowledge of medical terminology.
• Knowledge of science or a scientific background is preferred.
• Good oral and written communication skills.

Preferred

• Through knowledge of Covance, the overall structure of the organization and Standard Operating Procedures (SOPs).
• Four or more years of Electronic Data Capture experience.
• Experience as a hands on Data Manager with capability of leading and driving all study related deliverables to ensure client expectations are being met in a timely manner and within budget.