Career Opportunities

Career Opportunities

Below are details of our current vacancies:

Senior Statistician

Section: Statistics

Job Description: Responsible for leading all statistical activities relating to clinical trials.

Areas of responsibility include:

  • Providing expert point of contact with sponsor and internal project teams
  • Leading projects and delivering on time and within budget
  • Protocol and sample size consultancy
  • Randomisation design
  • Data capture design review and input into data standards
  • Development of Statistical Analysis Plans
  • Statistical programming and modelling
    • Meta-analysis
    • PK/PD and bioequivalence studies
    • Mixed models
    • Adaptive designs
    • Survival analysis
    • ISS/ISE
  • Expanding the department expertise in other areas of statistics
  • 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
  • Project management including resourcing, financial planning and budgetingGeneral responsibilities include:
  •  Contributing to SQN’s development of new systems, processes and SOPs
  • Expert assistance in the help and compilation of bids and contracts
  • Business develop expert support – contributing to meetings
  • Ability to communicate effectively with non-statisticians

 

Experience and skills required: 

  • Strong analytical and data interpretation skills
  • Statistical programming and modelling with experience ideally across:
    • Meta-analysis
    • PK/PD and bioequivalence studies
    • Mixed models
    • Adaptive designs
    • Survival analysis
  • Minimum of 5 years in the Pharmaceutical or CRO Industries and preferably an MSc in Statistics or related discipline
  • 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

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: karen.grover@synequanon.com

Principal Quality Assurance Auditor

SQN is an award-winning Norfolk-based specialist clinical biometrics CRO supporting global pharma, biotech, medical device and animal health partners with innovative clinical development services. They have recently been awarded the Queens Award for Innovation.

 

SQN is looking to appoint a Principal Quality Assurance Auditor.

 

Reporting to the Manager, QA, you will provide day-to-day support, guidance and supervision for the quality assurance function. You will be responsible for managing the Quality Assurance program component within the organization and will work with the other departments to assure regulatory compliance and consistency with the policies and procedures. Your experience, knowledge and ideas will help influence SQN’s continued innovation and business growth.

 

Main Responsibilities:

  • Administration of the Quality Assurance department as directed by the Manager, QA
  • Assist the Manager, QA in setting up the quality audit programme
  • Deputise in the management and training of a team of 3 QA auditors
  • Ensuring the quality audit programme is followed and kept up to date
  • Perform and provide guidance on internal and external audits.
  • Oversee production of a regular report to management using QA metrics and escalate any issues for concern to the Manager, QA.
  • Where required produce training documentation relating to quality and regulatory areas for both QA and Company.
    • Participate to Client audits and regulatory Inspections (preparation, hosting, responses and follow up of corrective action plans)
    • Support to the development and deployment of exciting and innovative patient centric technology. Profile Required
    • GCP and CSV QA experience.
    • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
    • Experience with assisting or managing a team.
    • Experience with assisting or managing QA audits and inspections as well as interfacing with regulatory agencies.
    • Experience in the management of documents (Policies, SOPs etc.).
    • Expert knowledge of GCP and applicable regulations
    • Demonstrates leadership ability, communication, and facilitation skills.

 

Position Location

Office based in Diss Norfolk (preferred); or

  • Will consider flexible working including some home-based working.
  • Full-time contract
  • To start December 2017

Please send your resume and your contact information to: info@synequanon.com

Senior SAS Programmer

Section: Statistics

Job Description: Responsible for statistical programming activities relating to clinical trials. Senior programmer will additionally be responsible for leading the programming activities on studies.

Areas of responsibility include:

 Primary areas:

  • CDISC SDTM mapping and programming. Creation of SDTM mapping specs, SDTM defines and reviewer’s guides
  • Senior 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
  • Contributing to SQN’s development of new systems, processes and SOPs  

 

Experience and skills required:

  • 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 preferable
  • 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 please submit your application and CV to: karen.grover@synequanon.com

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