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RESPONSIBILITIES:
- Provide statistical input for protocol development, study design, and CRF development by actively contributing to study design considerations in internal and client meetings, and providing and discussing sample size scenarios
- Perform sample size calculations and write statistical methodology sections for inclusion in study protocols
- Oversee production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
- Design statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for New Drug Application (NDA) submissions
- Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards if applicable
- Develop SAS programs to produce and/or QC statistical tables/figures/data listings
- Perform mapping from raw datasets to CDISC SDTM datasets
- Produce and perform quality control of define.pdf, define.xml and annotated case report forms for SDTM submission
- Develop SAS programs to produce and validate analysis datasets in CDISC ADaM or other formats specified by the sponsor and CDISC SDTM datasets from raw data
- Review and/or write the statistical and results sections of clinical study reports
- Review and/or assist in writing publications
- Review case report forms and data validation guidelines to ensure quality and integrity of study data collection
- Manage multiple projects
- Provide statistical input for Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, and serve as an independent statistician providing data and analysis support for DMC review
- Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical methodology and analysis
- Support proposal development and attend bid defense meetings
- Review Request for Proposal (RFP) and Scope of Work (SOW) documents
- Understand the SOW, budget and task assumptions, and track work completed versus budgeted tasks
- Manage project budget and forecast resources needed for studies
- Additional responsibilities as assigned by supervisor/manage
Compensation Details:
- Orbis Clinical provides a reasonable range of compensation for this position. 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 $115,000 - $190,000.
EEO and Reasonable Accommodation Statement:
Orbis Clinical provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, housing, age, disability or genetics.
We will consider all qualified applicants for employment, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws.
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.
Fill out the form below to get in touch with our business development team, or call us at (781) 328-1132.
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.