Principal Statistical Programmer

Highly Competitive
  1. Permanent
  2. Statistics
  3. Germany
Berlin, Germany
Posting date: 09 Dec 2020
34587

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.

Job Responsibilities

  • 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.

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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