Statistical Scientist/ Sr Statistical Scientist

Job description

·  Job facts

You will be aligned therapeutically with cross-functional Medical Affairs teams to provide statistical and analytical leadership in the development and execution of medical strategies, plans and projects.

Like other team members in Biostatistics, you will be responsible for the statistical integrity, adequacy and accuracy of pre-launch, launch and post-marketing clinical studies other investigations and assessments, including exploratory analyses. As such, you will be a standing member of the assigned Medical Team, may also lead Biostatistics teams, as well as participate in other cross-functional projects or working teams.

Given the nature of their positions, statistical scientists also work closely with their counterparts in Pharmaceutical Development and potentially Pharmaceutical Research and Early Development to align clinical data and statistics across varying drug development phases.

You will be expected to perform your responsibilities with increased expertise and independence. Where assigned, you will also act as Medical Affairs representatives in related review and decision-making forums or committees, including, where applicable, representing Biostatistics input and data in health authority meetings, presentations and communications.

All Roche employees are expected to effectively contribute to cross-functional collaboration and coordination and comply with all laws, regulations, policies & procedures that govern our business.

Job Qualifications

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following knowledge, skills and abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” or as a “plus,” all points listed below are considered minimum requirements. Years of experience listed below can be substituted with equivalent, relevant competency levels.

·  Ph.D. or M.Sc. with 2+ relevant industry experience, in Statistics/Biostatistics or related fields
·  Sound knowledge of theoretical and applied statistics
·  Relevant therapeutic experience is a plus
·  Sound knowledge of Phase IV/post­-marketing drug development (knowledge of or experience with Phase I – III drug development is preferred)
·  Good understanding of GCP (Good Clinical Practice) and ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines
·  Proven experience in the principles and techniques of data analysis, interpretation and clinical relevance
·  Sound understanding of regulatory guidelines for drug development
·  Working experience with real world data and high dimensional data is a plus

Skills/Abilities

·  Proven abilities to perform statistical scientist responsibilities with increasing expertise and independence
·  Has demonstrated, through past experience, abilities to competently manage the majority of biostatistics deliverables associated with assigned pre­launch, launch and/or post-­marketing medical strategies, plans and tactics
·  Analytical and problem­ solving capabilities and skills
·  In-­depth knowledge of the multi­disciplinary functions involved in a drug development process, and can proactively integrate multiple perspectives into the post-­marketing process for best end results
·  Excellent project management skills
·  Strong interpersonal, verbal and writing communication, and influencing skills
·  Proven track record of working highly effectively, efficiently and collaboratively with others
·  Proven experience and skills working with multi­disciplinary teams
·  Proficient computer skills, including Microsoft Word, PowerPoint, and Excel
·  High­ level of proficiency with SAS, R, and related statistical software packages

CMG Operating Principles

I put the patient first, always.

I am tenacious in meeting customer needs.

I act on behalf of the whole company, not just my team.

I am inclusive.

I build a culture of trust.

I grow my capabilities to increase my impact.

I have a bias for action.

I am accountable.

I use time and resources to create the most impact.

Roche is an equal opportunity employer.
Research & Development, Research & Development > Biometrics

·  Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

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.