This role will provide leadership in all aspects of clinical trial research and product development as well as regulatory interactions.  Participation in the selection and oversight of the CRO to perform data management, programming, and biostatistics will be included in this role.  Consultant will be available to participate in all meetings as needed, whether they be internal or with regulatory authorities.   Specific tasks include but not limited to:  Review of Programming as performed by CRO including- ADaM Specification, ADaM Programming, ADaM CDISC Compliance Checking, ADaM define.xml, etc., Stats analysis plan, lead data review meetings, review & contribute to protocol, study report, prep DMC charter and DMC meeting participation, briefing books as needed, any other biostatistician ad hoc support.

Project Start-up:

•  Documents Review ·
• Project Set-up

Sr. Biostatistician & Strategist level CRO Oversight

• • Review of Programming as performed by CRO. All of the following will be produced by the chosen CRO. Biostatistician will review each to ensure highest quality:
    • ADaM Specification
    • ADaM Programming
    • ADaM CDISC Compliance Checking
    • ADaM define.xml
    • Analysis Data Reviewer’s Guide (ADRG.PDF)
    • Unique Tables
    • Repeat Tables
    • Unique Figures
    • Repeat Figures
    • Listings
    • Dry Runs

Statistics:

• Statistical Analysis Plan Support (Author SAP, prepare table shells, TLF Review (TLFs produced by CRO) and checking for integrity). This will involve delivery of draft SAP to team, and two revisions prior to approval.
• Lead Data Review Meetings (at 50%, 75%, 90% of completion of study. TLFs to be delivered by CRO)
• Meeting Participation during conduct of study
• Review of Clinical Study Report and QC

DMC activities

• Prepare DMC Charter (Author and oversee the DMC Charter following the FDA Guidance for Data Monitoring Committees). This will require involvement from the Clinical team, who will review the draft charter. Two revisions of the charter will be produced and the charter will then be approved.
• Meeting Participation for the open session of each DMC meeting. The DMC will then meet in a closed session and will provide advice to the CMO as to decision (per DMC charter)

FDA activities

• Participate in the preparation of briefing books as needed for all FDA meetings.
• Participate in all rehearsals for meetings as well as all meetings (face-to-face or by teleconference)

Adhoc activities

• During the course of a clinical trial it may become necessary to provide unplanned support. Biostatistician will be available at all times to provide such support and will ensure that there are no delays based upon need for Biostatistics support.

Expected: 600 hours per year for 2 years. It is understood that some weeks and months will require more hours than others. Consultant will flex as needed.