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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.
The Company is an equal opportunity employer and makes employment decisions on the basis of merit. The Company prohibits unlawful discrimination on the basis of race, color, national origin, ancestry, religion, creed, age, sex, sexual orientation, gender identity, pregnancy, marital status, physical or mental disability, medical condition or any other consideration made unlawful by federal, state or local laws. The Company will also provide reasonable accommodation to the known physical or mental disability of an otherwise qualified employee or applicant. Should you need any such accommodation, please contact the Company for further information. The Company is dedicated to ensuring that all decisions regarding personnel are in accordance with all applicable laws. I certify that all statements made in this application are true to the best of my knowledge. I understand that all falsification or misleading information given in my application may result in the termination of my employment with Orbis Clinical and its subsidiaries. Furthermore, I understand that my professional conduct and clinical performance is directly related to my ability to be placed on assignments for Orbis Clinical and that I will adhere to all regulations and guidelines of Orbis Clinical. I authorization Orbis Clinical to verify the information I have provided, to contact references, and to conduct criminal, education and personal background checks concerning my qualifications, and past employment record. I understand that nothing contained in this application is intended to create an employment contract, either verbal or written, with Orbis Clinical or its clients. Furthermore, I understand that my employment, it is “at will” and Orbis Clinical or I may terminate my employment at any time with or without notice and with or without case. I acknowledge that I will be legally obligated by the terms of this document by typing my name, which will constitute my signature, or manually signing, in the provided space and electronically transmitting this document to Orbis Clinical. I agree that Orbis Clinical and I may use electronic means to conduct this transaction and that this document shall be governed and construed by the laws of the State of Massachusetts.
