Principal Statistical Programmer
An excellent CRO are looking for an experienced Principal Statistical Programmer to join their PBS division. This organisation is experiencing exponential growth on a global scale in our Project-Based Services (PBS) team. The Statistical Programmer will support Phase I -IV clinical studies across a variety of therapeutic areas. If you thrive working in a challenging, multi-tasking, deadline-driven environment, you will fit in well with this fantastic organisation.
- 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 .
Skills and Requirements
- Bachelor's degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
- Minimum 10 years of SAS programming experience supporting clinical trials in the Pharmaceutical & Biotech industry.
- 5+ 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.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.