Job Title: Study Lead Statistician - Product Facing

Location: Remote

Contract: 12 months

Description:

• The Study Lead Statistician (SLS) for product facing work is responsible for leading statistical activities of clinical studies.
• The SLS works closely with cross-functional team members to ensure their clinical studies are appropriately planned, have the required statistical power for success, comply with Regulatory requirements and company standards, and maintain statistical, as well as operational, integrity throughout the life of the study.
• The SLS works closely with the Global Statistical Lead to ensure their study aligns with the overall product strategy.
• The SLS also works closely with the Study Statistician, who performs all the operational activities related to the statistics-related deliverables.
• The SLS is responsible for the integrity and quality of their study.
• The SLS also supports product level activities that could include Regulatory activities as well as publication work.

Core Responsibilities:

• Provide statistical guidance, review, and contribution to protocols, SAPs; TFL shells; DMC Charters; SDF specifications (SDTM and ADaM); randomization specifications; other key-study related documentation, protocol deviations, data quality review, and other communications
• Attend and be a contributor at Clinical Study Team Meetings
• Attend meetings for and provide statistical input into cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review
• Initiate cross-functional team meetings as necessary (e.g., SAP review, TFL shell review, TFL review)
• Provide statistical guidance, review, and be responsible for statistical analysis of individual studies/projects
• Perform and document QC of primary and key secondary endpoints within ADaM datasets as well as the statistical analyses of these endpoints (programmatically)
• Perform data-driven modeling during clinical studies
• Coordinate the creation of required outputs for Dose Level Review Meetings (DLRMs) as well as coordinate and participate in the DLRM
• Review TFLs created by statistical programming for consistency and accuracy
• Author analysis reports such as Flash Memo, and results section of the CSRs
• Collaborate with the study programming team for study deliverables
• Manage timelines for all statistics-related deliverables by working with the cross-functional team members (e.g., programmers, study statisticians, clinical data managers, medical writers)
• Be familiar with all Companys policies, SOPs and other controlled documents related to study activities noted above
• Assist with study and systems audits conducted by Company GCA and external bodies

Day to Day Responsibilities:

• This study lead statistician will support the cross-functional team in leading the statistical aspects of study design and execution for one or more clinical trials in all phases of drug development. Responsibilities include supporting protocol development, leading development of statistical analysis plans, supporting study execution and analysis and interpretation.

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 $91.90 - $109.15 per hour, can vary depending on employment status.
• Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.

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.