Job ID: JOB_ID_4511
Job Description: Senior Biostatistician
Our client, a leading gene and cell-therapy company based in Boston, is seeking a highly skilled Senior Biostatistician to provide crucial support for their late-stage submissions. This is a remote position, with a preference for candidates in the Eastern Standard Time (EST) zone, requiring flexibility to attend meetings during EST business hours.
Key Responsibilities:
- Write and update Statistical Analysis Plans (SAP) to guide study design and analysis.
- Design Table, Figure, and Listing (TFL) shells and outputs for individual studies, as well as Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE).
- Perform validation and quality control (QC) of SAS programming to ensure accuracy and reliability of statistical outputs.
- Provide broad biostatistics support for late-stage submissions, including NDA/BLA.
- Collaborate with cross-functional teams, including SAS programming and statistical teams, to ensure robust data analysis and reporting.
Special Requirements:
- Extensive experience with late-stage submission processes, specifically New Drug Applications (NDA) and Biologics License Applications (BLA).
- Proficiency in SAS programming is essential for data analysis and reporting.
- This role is designed to be a supportive position, ideally filled by an individual at the Senior Biostatistician or Associate Director (AD) level.
- Must possess a LinkedIn profile.
- Managerial references are required.
Logistics:
- Contract Duration: 6 months
- Work Hours: 40 hours per week
- Start Date: Imminent
- Location: Remote (EST time zone preferred for meeting availability)
- Reporting Structure: Reports to the Sr. Director of Biostatistics.
Vetting Process:
- The interview process includes an initial interview with the Sr. Director of Biostatistics, followed by a second interview with one of her statistics or SAS programming team members.
This is an excellent opportunity to contribute to a cutting-edge gene and cell-therapy company and play a vital role in bringing life-changing therapies to market.
Special Requirements
Visa constraints: None specified. Screening steps: Interview with Sr. Director of Biostatistics, then one of her stats/SAS programming team members. Interview modes: Not specified. Domain restrictions: Gene and cell-therapy company.
Compensation & Location
Salary: $120,000 – $180,000 per year (Estimated)
Location: Boston, MA
Recruiter / Company – Contact Information
Recruiter / Employer: Boston
Email: shu.moolchandani@tekinspirations.com
Recruiter Notice:
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