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Orbis Clinical is seeking a remote based Temp - Biostatistician ( (multiple openings) ) for a 6 month contract.
Job Title: Temp - Biostatistician (General Med) - REMOTE
Location: Remote (EST hours preferred)
Contract: 6 months
Most ideal candidate background: Sponsor-side or sponsor-embedded PhD/MS biostatistician with 5–8+ years of hands-on Phase II/III study statistician experience, ideally in General Medicine or a transferable TA, with strong SAP, protocol, TFL, CDISC, CSR/submission, and cross-functional study team experience.
When & where:
- Remote from US (must be able to support US EST Time zone)
- Occasional travel could be required
Build our future together:
We use science and innovation to develop life-changing medicines for people with serious diseases. The Biostatistician implements and executes methodological and statistical aspects of clinical studies under the supervision of Therapeutic Area lead biostatistician or project lead statistician. In some cases, principal function could be to develop/employ technical expertise in a particular statistical area or application.
Discover your role:
- Under direct supervision and guidance of senior departmental staff, provide support to a clinical study
- team on all relevant statistical matters. As member of study team, ensure the clinical study is conducted
- in a manner that supports planned statistical analysis.
- Under supervision and guidance of senior departmental staff, participate in preparation of study protocol
- and amendments. Perform relevant sample size calculations and write statistical methodology section of
- the protocol.
- Review case report form (CRF) and provide comments and feedback.
- Develop statistical analysis plan (SAP).
- Provide programming team with definitions and documentation for derived variables needed to produce
- planned Tables, Figures and Listings (TFLs). Develop data and programming specifications jointly with
- programmers.
- Perform statistical analysis according to the SAP, validate analysis programs, review TFLs, prepare
- statistical methods and results sections for the clinical study report (CSR), provide statistical insight into
- interpretation and discussion of study results, and work with the study team to move the CSR through
- review /approval process.
- Support/participate in project related activities including preparation of BLA submissions and oversee
- CRO deliverables for studies contracted out
This role requires:
- Master Degree in related field required | PhD preferred
- Min of 2+ years of relevant experience (ideally would have 5-8years of relevant experience)
Keywords:
study statistician, project statistician, clinical biostatistician, SAP, TFL, CSR, protocol, sample size, interim analysis, Phase 2, Phase 3, CDISC, ADaM, SDTM, SAS
Compensation Details:
- Orbis Clinical is an equal opportunity employer that 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 $70.00 - $95.00 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.
