Clinical Pharmacology Data Scientist - PKPD programming

Job description

·  Job facts

At Roche, we believe it's urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients' lives and we are fearless in both decision and action. And we believe that good business means a better world.

That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

Roche Pharma Research and Early Development (pRED) translates exceptional science into medical innovation through a diversity of technologies and talent located across seven research sites worldwide. We deliver on individual patient needs through a deep understanding of disease biology and the implementation of Personalized Healthcare strategies.

The Clinical Pharmacology and Bioanalytical Research and Development department supports the research and development of transformative therapeutics through state of the art Clinical Pharmacology approaches and world leading bioanalytical technologies. This expertise allows us to characterize Pharmacokinetics and Pharmacodynamics and sources of variability in the relationships between dose, exposure and response for our drugs and thereby to guide selection of the best dose regimens.

As a Clinical Pharmacology Data Scientist (CPDS) you would support the conduction of Clinical Pharmacology activities. You conduct exploratory analysis, model-orientated and model-based graphical evaluation of data. And you are also accountable for delivering ready to use analysis dataset (descriptive dataset, pooled and cleaned ready to use modeling input dataset, NCA). You are expected to acquire the basic pharmacometrics knowledge required to perform such tasks and to stay abreast with and learn new Quantitative Clinical Pharmacology tools and techniques.

Major Responsibilities and Accountabilities

·  Conduct model-orientated and model-based graphical evaluation of M&S data (e.g. bayesian feedback analysis using prior model) in consultation with the clinical pharmacometrician
·  Conduct exploratory analysis in consultation with the clinical pharmacometrician, clinical pharmacology
·  Lead the creation of pooled and cleaned ready to use modeling datasets (e.g. NONMEM® dataset) and descriptive datasets in compliance with Roche internal guidelines, standard operating procedures (SOPs) and Health Authority guidelines through high quality programs.
·  Lead the creation of NCA datasets in compliance with Roche internal guidelines, standard operating procedures (SOPs) and Health Authority guidelines through high quality programs.
·  Assist in the development of pharmacokinetic, pharmacodynamic and physiological models under the supervision of the clinical pharmacometrician
·  Participate in the writing of M&S analysis plans and M&S reports
·  Support quality control of M&S deliverable such as datasets, tables, listings and figures.
·  Contribute to, and sometimes lead, process-improvement initiatives
·  Assist in the assessment, development and documentation of new tools
·  Provide input into Case Report Form (CRF) design for M&S data collection.

Qualifications:

You own a Master of Science (M.S.) or Bachelor of Science (BSc) or equivalent experience in Mathematics and Statistics, with at least 2 years experience in a similar role or 4 years in a statistical programming role.

Experience and/or Competencies Required

·  Efficient in SAS®
·  Experience in data pooling and graphical representation
·  Deep understanding of drug development process including global clinical trial practices, procedures, methodologies
·  Highly effective verbal and written communication/presentation skills in English
·  Ability to process information, analyze data, and reach conclusions based on good judgment
·  Other (valuable, but not mandatory)
·  Overview of clinical pharmacology and meaningful biological and medical concepts
·  Overview of PK, PD, NCA and modeling
·  Consistency, Sense of Urgency, Drive to Change, Innovation
·  High Performance

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be a rare springboard to many other opportunities at Roche.

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills.

The more inclusive we are, the better our work will be.

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.