George Higginson is searching for an experienced Principal Statistical Programmer for my top-5, global CRO client. As a Principal Statistical Programmer, you will be part of a top CRO team, engaging in a wide range of interesting and challenging tasks including writing ADaM specifications, programming ADaM dataset, programming efficacy outputs, and submission work and of course gaining exposure to other languages such as R.
Within this role, you have x3 options on which group you'd like to pursue your career in:
- Principal Statistical Programmer – Early Phase – SDTM & ADaM
- Principal Statistical Programmer – Phase II/III – ADaM ONLY
- Principal Statistical Programmer – Phase I/III – SDTM ONLY
- Providing significant technical expertise for statistical programming in all phases of programming support, developing automated reports and preparation of submission data standard packages.
- Supporting statistical programming activities for multiple and/or large/complex drug/vaccine clinical development projects.
- Development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), Design and maintenance of statistical datasets that support multiple stakeholder groups.
- Serving as key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.
- Being able to serve as statistical programming point of contact and knowledge holder through the entire product lifecycle for the assigned protocol if/when called upon.
- Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.
- Maintaining and managing a project plan including resource forecasting.
- Coordinating the activities of the supplier’s programming team; and interacting with client statistical programmers.
- Utilizing strong project management skills and ability to engage key stakeholders; leadership at a protocol level; determining approach and ensuring consistency, and directing development of others when opportunities arise.
- Designing and developing complex programming algorithms.
- Comprehending analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts.
- Utilizing expertise in CDISC and ADaM standards.
- Statistical programming for early and late stage clinical trials which can include both planned and ad-hoc needs.
- Enriched / Post Processed Datasets (individual or integrated).
- ADaM datasets (individual or integrated).
- Protocol and therapeutic area specific tables, listings, and figures (individual or integrated). Programming documentation following SOPs .
- Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
- Minimum 7+ years of SAS programming experience supporting clinical trials in the Pharmaceutical & Biotech industry.
- 2+ years of study lead experience working with cross functional teams, including leading programming teams.
- Minimum 3 years of recent experience supporting Oncology studies.
- Strong experience in QCing and validating work of other programmers, preferably outsourced work.
- Strong SAS data manipulation, analysis and reporting skills - with strong output programming experience.
- Strong proficiency implementing the latest CDISC SDTM / ADaM standards.
- Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
- Submissions experience utilizing define.xml and other submission documents.
- Excellent analytical & troubleshooting skills.
- Ability to provide quality output and deliverables, in adherence with challenging timelines.
- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
How To Apply
AL Solutions is a niche Life Science recruitment consultancy. We place professionals across the UK, Europe, the United States and Canada for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies.
Tel: +44 (0) 203 778 0909