Latest Jobs at Covance

Job Overview

• Principal Statistical Programmer required to work for Covance as an experienced Lead Statistical Programmer on studies in Phases I-II
• You will be employed by Covance and work within our FSPx department 100% dedicated to one Sponsor
• Office based in in any of our European or South African offices or home based anywhere in Europe or South Africa
• You must have previous experience as a Lead Statistical Programmer within a biotech, CRO or pharma company
• Strong Oncology experience would be an advantage
• Opportunities to develop and progress

Discover new opportunities to grow your career as a Covance FSP Principal Statistical Programmer. Our partner has an incredibly exciting and strong pipeline with over 45 ongoing oncology studies in Phases I and II. The position offers a strong support network, flexible working solutions and the opportunity to progress your career. If you are looking to strengthen your Lead expertise whilst gaining exposure to a pharmaceutical working environment this is a fantastic opportunity.
This is an incredibly exciting time to be joining Covance as we continue to grow and expand. This is a full-time home or office-based role anywhere within Europe or South Africa.

What is FSP?

At Covance, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).
As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise.
Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Covance studies.

With the support of exceptional people and an energized purpose, you’ll be empowered to own your career journey with dedicated mentoring, training and personalized development planning. Further information can be found at: https://www.covance.com/services/functional-service-provision.html

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

Experience:

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

Education/Qualifications:

• Experience as lead statistical programmer on complex studies in clinical research 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.
• Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards
• Candidates must be fluent in English language (both verbal and written)

PLEASE NOTE CANDIDATES WHO DO NOT FULFIL THE CRITERIA MAY NOT RECEIVE A RESPONSE

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Job Overview

• Senior Biostatistician required to work for Covance leading studies in Phases I and IIa/b
• You will be employed by Covance and work within our FSPx department 100% dedicated to one Sponsor
• The Sponsor is a top 20 bio-pharmaceutical company and they have a very exciting and strong oncology pipeline
• Office based in any of our European or South African offices or home based anywhere in Europe or South Africa
• You must be an experienced Biostatistician with strong oncology experience gained within a CRO/Pharma
• Candidates must be fluent in English language (both verbal and written)
• Pro-active attitude, good communication and project management skills required

Discover new opportunities to grow your career as a Covance FSP Senior Biostatistician. Covance FSP are looking to hire a Senior Biostatistician with experience in Oncology. Our partner has an incredibly exciting and strong oncology pipeline with over 40 ongoing studies in Phases I and II. You will be part of a team dedicated to early phase (Phases I, IIa and IIb) Oncology projects. The position offers a strong support network, flexible working solutions and the opportunity to raise your profile in the industry. If you are looking to strengthen your therapeutic expertise within oncology whilst gaining exposure to a Bio-Pharmaceutical working environment this is a fantastic opportunity.

Job Primary Functions

• Perform Lead Biostatistician role on medium complexity studies, providing statistical oversight and attending relevant project meetings
• Perform project management activities for identified projects including resource planning, timelines and milestone management
• Preparation of Statistical Analysis Plans (including mock TFL shells) for medium complexity studies under the supervision of more senior statistical staff
• Perform complex statistical analyses, quality check statistical analyses developed by other statisticians
• Conduct overall statistical review of TFLs for complex studies prior to client delivery
• Review CRF and other study specific specifications and plans
• May perform sample size calculation for simple studies under the supervision of more senior statistical staff
• Develop the statistical sections of the protocol for simple to medium complexity studies under the supervision of a statistical consultant
• Provide statistical input and review of the CSR for medium complexity studies
• Preparation and review of randomization specifications and generation of randomization schedules
• Mentor of biostatisticians within project activities; assigned tasks related to the development of staff within the department
• Present and share knowledge at team meetings and/or at monthly seminars
• Attend bid defense meetings for medium complexity studies in order to win new business
• Represent the department during project-driven client audits.
   

Education/Qualifications

• Master’s degree, equivalent, or higher in Biostatistics or related field

Experience:

• You must have previous Lead experience working as an experienced Biostatistician in either a biotech, CRO or pharma company
• Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses. SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis
• Ability to effectively communicate statistical concepts
• A good knowledge of the overall clinical trial process
• Experience in the preparation of Statistical Analysis Plans, analysis, reporting, etc
• Candidates must be fluent in English language (both verbal and written)

PLEASE NOTE CANDIDATES WHO DO NOT FULFIL THE CRITERIA MAY NOT RECEIVE A RESPONSE