Biostatistics Temp - Biostatistician (Gen Med & Internal Med) - REMOTE Tarrytown, New York

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.