Principal Statistical Programmer PBS

JOB DESCRIPTION

You will report to the Director, Statistical Programming.

You will contribute by:

• 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 .

What you offer:

• Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
• 7-8 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development with good knowledge of CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines.
• Study lead experience working with cross functional teams, including leading programming teams.
• 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.

• Our collaborative working environment encourages innovation and rewards results, and we are proud to have one of the lowest turnover rates in the industry.
• In addition to a competitive compensation, we offer an excellent benefit’s package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us!
• Work with respected experts and thought leaders in the fields of biostatistics and statistical programming.