Biostatistics Senior Principal Biostatistician (US)-REMOTE California

Orbis Clinical is seeking a remote-based Senior Principal Biostatistician for 6 months.

The Principal Biostatistician will be responsible for performing and validating statistical analyses in support of the clinical trial portfolio, in accordance with departmental SOP and guidelines, as needed and sit within the Data Sciences department.

Essential Functions

·      Support the development and implementation of study protocols.

• Review and provide input to data capture systems and participate in their validation.

·      Support clinical development biostatistics with exploratory analyses necessary for submissions and regulatory queries.

• Work collaboratively with members of study teams to meet study and recurring report timelines.
• Support the development and implementation of study protocols.

·      Review and contribute to protocol, eCRF design, dataset specifications plans at study level in accordance with best practices.

• Write statistical analysis plans, review statistical analysis plans written by other statisticians, perform and oversee data analysis and validation, and interpret analyses.
• Develop statistical programs as necessary to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming.
• Create and document archives of programs, outputs, and analysis files.
• Collaborate as the statistical subject matter expert with medical writers in the production of clinical reports, integrated summaries, and other documents.
• Learn drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards.

Minimum Requirements

·      Master’s degree with >2 years of experience; OR PhD in statistics, mathematics or a related discipline with a statistical focus.

·      Proficient in drug development regulations pertinent to statistical analysis and in the Oncology/Neuroscience therapeutic space

·      Proficient SAS & R programming skills

·      Understanding of CDISC SDTM and ADAM models and standards is preferred.

·      Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills.

·      Able to work in a fast-paced, flexible, team-oriented environment.

Compensation Details:

• Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location. 
• The Pay Range for this position is $70-$82 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). .

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.