Career Opportunities

Double Queens Award winning SQN Clinical is one of the largest specialist data focused contract research companies in Europe supporting human clinical trials developing new life-saving drugs. Using its innovative Electronic Data Collection system, ePRO mobile app and related biometrics services, SQN is a market leader in the healthcare arena. The Norfolk based specialist clinical biometrics CRO is supporting global pharma, biotech, medical device and animal health partners with innovative clinical development services.

This is an exciting and varied opportunity to join a well-established team with responsibility for leading all statistical activities relating to clinical trial projects. Being a statistical expert able to provide statistical consultancy in specific areas.

Areas of responsibility include:

• Providing statistical expert point of contact with sponsor and internal project teams
• Randomisation design, Protocol and sample size consultancy
• Performing the Lead Statistician role on varied and complex projects; delivering to client expectations and within budget
• Development of Statistical Analysis Plans
• Covering a variety of statistical consultancy, programming, and modeling based on the awarded work, for example:
  • ISS/ISE
  • Meta-analysis
  • PK/PD and bioequivalence studies
  • Mixed models
  • Adaptive designs
  • Survival analysis
• Supporting the development and expansion of statistical expertise at SQN
• Peer review of statistical deliverables
• Providing statistical expertise and presentation of results at sponsor meetings
• Providing statistical evaluation and reports for inclusion into Clinical Study Reports

General responsibilities include:

• Advising on statistical issues, expanding the department’s knowledge base
• Contributing to SQN’s development of new systems, processes, and SOPs
• Business development expert support – contributing to proposals, contracts, and meetings
• Ability to communicate effectively with non-statisticians

Experience and skills required:

• Strong analytical and data interpretation skills
• Advanced statistical expertise in a variety of area and topics
• Statistical programming and modeling with experience across a wide variety of topics
• Experience in Integration studies preferred
• Minimum of 5 years in a CRO environment and an MSc or Ph.D. in Statistics
• Excellent project management, organisational and matrix management skills with the ability to proactively prioritise projects
• Budgeting and resourcing skills
• Leadership and mentoring skills
• Commercial awareness
• Experience with SAS v. 9
• Wide clinical development knowledge across Phase I through IV studies, real world, integration studies

If you have the necessary experience, qualifications and skills and are interested in being considered for this full-time permanent position please submit your application to: info@synequanon.com

Responsible for statistical programming activities relating to clinical trials. Principal programmer will additionally be responsible for leading the programming activities on studies.

Areas of responsibility include:

Primary areas:

• CDISC SDTM and ADAM mapping and programming. Creation of SDTM and ADAM mapping specs, SDTM and ADAM defines and reviewer’s guides
• Provision of expert advice and technical support to study teams
• Principal role will include project leadership activities

Additional areas:

• Development of analysis dataset specifications
• Development, maintenance and validation of SAS® programs for the production of analysis datasets and tables, figures and listings for inclusion in clinical study reports
• Creation and review of shells for tables, figures and listings from a programming perspective
• Development, maintenance and validation of SAS based utilities
• Data capture design review and input into data standards
• Lead role in SQN’s development of new systems, processes and SOPs

Experience and skills required:

• Current and extensive proven technical experience performing this role with a proven track record in leading study teams
• Subject matter expert in one or more areas
• Self-motivated with the ability to motivate others
• Expertise in CDSIC SDTM standards, including thorough understanding of SDTM IG, creation of SDTM mapping specifications, defines and reviewer’s guides. Experience in the conversion of data sets into SDTMs
• The equivalent knowledge of ADaM standards essential
• Experience of running data integration projects
• Strong analytical, programming and data interpretation skills
• Minimum of 8-9 years SAS® programming experience ideally in the CRO environment
• Good organisational skills with the ability to proactively prioritise projects and allocated activities
• Experience of leading project teams, forecasting work and assessing progress
• Budgeting and resourcing skills
• Leadership and mentoring skills
• Commercial awareness
• Practical experience with SAS v 9 and macro development
• Understanding of clinical development processes
• Excellent communication skills and high level of English language

If you have the necessary experience, qualifications and skills and are interested in being considered for this full time permanent position please submit your application and CV to: info@synequanon.com

Responsible for project management activities relating to clinical trials

As a Senior Project Manager at SQN, your role will be to provide strong leadership of biometrics programmes to ensure high quality and timely project delivery to client satisfaction and budget. You will have the opportunity to be influential in shaping our project management practices with the freedom to devise innovative solutions for clients. As the main point of contact for a variety of clients in some exciting therapeutic areas, you will nurture client relationships, taking pride and satisfaction in exceeding their expectations by providing the personal service expected from a smaller biometrics CRO. With our innovative technology and partnerships with clinical CROs and technology vendors, you will lead exciting projects where your leadership skills will be challenged and rewarded.

Areas of responsibility include:

• Providing strong leadership and governance of biometrics projects, clients and third-party vendors
• Developing strong lasting relationships and providing expert guidance
• Determining client requirements and develop and maintain timelines, facilitating effective and efficient solutions to deliver to client expectations
• Leading and supporting internal project teams across the data management, statistics and medical writing functions
• Providing frequent updates to clients regarding project status, timelines and scope
• Managing project risks and issues, facilitating problem solving within project teams and escalating appropriately
• Leading bid defence meetings
• Assisting with the preparation of cost estimates
• Managing project budgets to ensure profitability including changes in scope, contractual documentation, invoicing and the maintenance of internal project management systems
• Conducting lessons learned reviews to ensure continuous and process improvements
• Ensure project quality, documentation and adherence to processes
• Contributing to SQN’s development of new systems, processes and SOPs
• Providing expert support to business development

Experience and skills required:

• Highly established project management, leadership and communication skills
• Strong client focus and commercial awareness
• Extensive experience in a similar role within pharma or CRO, managing timelines, budgets and quality across a portfolio of projects
• Thorough overview of cross-functional end-to-end processes for data management and statistics including a good understanding of regulatory requirements
• Excellent organisational and matrix management skills

The role can be office based or home based.

If you have the necessary experience, qualifications and skills and are interested in being considered for this full time, permanent, position please submit
your application to: info@synequanon.com

Responsible for the leadership and delivery of statistical programming activities relating to clinical trials.

Areas of responsibility include:

Primary areas:

• Acting as Lead Programmer across multiple studies
• Creation of CDISC compliant SDTM and ADaM programs and supporting documentation
• Senior role will include project leadership activities

Additional areas:

• Development, maintenance and validation of SAS® programs for the production of analysis datasets and tables, figures and listings for inclusion in clinical study reports
• Creation and review of shells for tables, figures and listings from a programming perspective
• Development, maintenance and validation of SAS based utilities
• Data capture design review and input into data standards
• Contributing to SQN’s development of new systems, processes and SOPs

Experience and skills required:

• Expertise in CDSIC standards, including a thorough understanding of SDTM/ ADaM IG, creation of SDTM and ADaM mapping specifications, defines and reviewer’s guides.
• Experience in the conversion of data sets into SDTMs
• Experience of running data integration projects
• Strong analytical, programming and data interpretation skills
• Minimum of 5-6 years SAS® programming experience ideally in the CRO environment
• Good organisational skills with the ability to proactively prioritise projects and allocated activities
• Experience of leading project teams, forecasting work and assessing progress
• Budgeting and resourcing skills
• Leadership and mentoring skills
• Commercial awareness
• Practical experience with SAS v 9 and macro development
• Understanding of clinical development processes
• Good communication skills and high level of English language

If you have the necessary experience, qualifications and skills and are interested in being considered for this full-time permanent position then please submit your application and CV to: info@synequanon.com

Double Queens Award winning SQN Clinical is one of the largest specialist data focused contract research companies in Europe supporting human clinical trials developing new life saving drugs. Using its innovative Electronic Data Collection system, ePRO mobile app and related biometrics services, SQN is a market leader in the healthcare arena. The Norfolk based specialist clinical biometrics CRO is supporting global pharma, biotech, medical device and animal health partners with innovative clinical development services.

This is an exciting and varied opportunity to join a well-established team with responsibility for leading all data management activities relating to clinical trial projects. Being a data management expert able to provide guidance and direction to both clients and team members.

Areas of responsibility include:

• Performing the Lead Data Manager role with responsibility for the successful quality, planning, execution, monitoring, control and finalisation of all data management activities with effective management of timelines, budget and quality.

• Planning: Definition and maintenance of Data Management project plan, input into the overall project plan. Responsible for the execution of all data management aspects of the project plan and reporting of status across the SQN project team.
• Resourcing: Definition of Data Management resource needs for the life time of the study including the identification and communication of short-term resource fluctuations. Flexible and efficient use of assigned resource.
• Documentation: Implementation and maintenance of accurate, clear Data Management documentation. Responsible for the setup, maintenance and finalisation of the Data Management Study File
• Study Team Management: Oversight of all data review activities; measuring progress against the project plan.
• Contract and Budget: Detailed knowledge and understanding of contracted Data Management obligations and associated budget; Ongoing assessment of budget, regular and accurate review of Data Management progress against financial milestones and monthly completion metrics.
• Client Management: Leads and drives all Data Management communication and acts as the primary client contact for Data Management activities
• Risk management and Escalation: Identifies, manages and communicates risk to timelines, quality and budget.
• Contributes to the ongoing development of the Data Management department through process analysis and improvement, mentoring, system enhancement.
• Liaises successfully with colleagues across the company to achieve a cohesive and co-ordinated service to our clients and the development of a strong Syne qua non team spirit. Supports Syne qua non’s business development activities.
• To effectively support regulatory and sponsor audits

If you have the necessary experience, qualifications and skills and are interested in being considered for this full-time permanent position please submit your application to: info@synequanon.com