Biostatistician Principal

Job description

·  Job facts

Provides statistical support to development and clinical research projects. Interacts with research personnel to ascertain their needs and develop appropriate design and statistical solutions. Writes statistical analysis plans and reports for use by internal and external customers. Critiques and improves study designs developed by other groups, and plays an active role in organizational surveillance to ensure statistical quality. Has primary ownership of at least one major project and actively mentors less experienced colleagues as needed. Functional support activities include providing training materials, presenting at internal and external professional conferences, identifying and solving technical challenges, developing and implementing novel statistical methodologies. Monitors work to ensure quality, and continuously promote Quality First Time.

Responsibilities

·  Interacts with development and clinical investigators to design clinical trials with appropriate statistical methods and adequate sample size for statistical justification of clinical utility claims.
·  Writes statistical analysis plans as needed to capture design elements and statistical methodology.
·  Performs data analysis and prepares statistical reports of results.
·  Performs quality control (QC) for statistical analyses by other biostatisticians to ensure analysis quality.
·  Conducts randomization and blinding of samples.
·  Develops data entry spreadsheets as needed.
·  Troubleshoots and improves current statistical designs, including those developed elsewhere in the organization.
·  Develops novel statistical innovations as needed.
·  Continuously monitors the organizational environment for opportunities to improve research design throughout the company.
·  Evaluates databases and statistical analysis programs and Interacts with data management and IT groups to determine hardware/software compatibility.
·  Maintains expertise in state-of-the-art data manipulation and statistical analyses, and actively mentors colleagues.
·  Manages day-to-day operational aspects of multiple projects.

Minimum Qualifications

·  Master's degree in in Statistics or a related field; Ph.D. in Statistics or a related field preferred
·  9 years of relevant experience with Masters; 6 years ofrelevant experience with PhD
· 
Significant experience in analysis and reporting using statistical software.

· 
Experience with SAS.

· 
Experience in FDA submissions and in vitro diagnostic tests.

· 
Design of Experiments (DOE) experience

· 
People management experience preferred

Travel Requirements: 10%, based on business needs.

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

·  Who we are

At Roche, 98,000 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.