Principal Statistician
Responsibilities: Responsible for leading all statistical activities relating to clinical trial projects. Being a statistical expert able to provide statistical consultancy in specific areas.
This is an exciting time to be joining an award winning CRO that is leading the industry in innovative use of technology and process improvements that adds significant value to the clinical development process.
Not just supporting the analysis and reporting of clinical trials, the SQN Statistics group is supporting advanced risk based approaches to clinical research with flexible reporting involving advanced data analytics, visualisation and adoption of AI concepts.
If you want to maximise your academic, commercial and management experience in a role that will be different, exciting and rewarding then it would be good to talk with you and for you to find out more
Areas of responsibility include:
- Providing statistical expert point of contact with sponsor and internal project teams
- Randomisation design, Protocol and sample size consultancy
- Leading projects and delivering on time and within budget
- Development of Statistical Analysis Plans
- Covering variety of statistical consultancy, programming and modelling based on the awarded work, for example:
- ISS/ISE
- Meta-analysis
- PK/PD and bioequivalence studies
- Mixed models
- Adaptive designs
- Bayesian methods
- Survival analysis
- Leading the expansion of 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
- Technical mentorship or line management
General responsibilities include:
- Providing expert advice 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
- Statistical expertise in a variety of areas and topics
- An expert within a therapeutic area
- Statistical programming and modelling with extensive current experience across a wide variety of statistical topics
- Worked on multiple studies with a creative approach to leading teams
- Experience with dealing with Regulatory Authorities
- Experience in Integration studies preferred
- Minimum of 5 years in the Pharmaceutical or CRO Industries for PhD in Statistics or minimum of 7 years with MSc in Statistics
- Line management or mentoring experience preferred
- Project management, organisational and matrix management skills with the ability to proactively prioritise projects
- Budgeting and resourcing skills
- Proven Leadership skills
- Commercial awareness
- Experience with performing statistical analysis using SAS v. 9
- Experience and understanding of CDISC
- 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
Senior SAS Programmer (2 Vacancies)
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: info@synequanon.com
Senior SAS Programmer (2 Vacancies)
Section: Statistics
Job Description: 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
