Are you a senior statistical expert seeking a high-impact submission role? A leading biopharmaceutical innovator is hiring a Remote (US) Principal Statistician for a crucial 9-month contract. Serving as a key individual contributor and unblinded lead, you will drive statistical review, double-programming QC, and dataset validation for a pivotal Phase III database lock, Integrated Summary of Safety (ISS), and eCRT submission package targeting NDA filing.
location: Malvern, Pennsylvania
job type: Contract
salary: $80 - 95 per hour
work hours: 9 to 5
education: Doctorate
responsibilities:
- Perform independent statistical review and SAS programming QC of unblinded final analysis outputs for a pivotal Phase III study.
- Conduct statistical review and QC of SDTM/ADaM datasets and eCRT submission packages to ensure CDISC compliance.
- Execute independent statistical review and QC of ISS analysis outputs and integrated datasets.
- Navigate strict blinding and unblinding operational boundaries throughout database lock to safeguard trial integrity.
- Collaborate cross-functionally with Medical Writing, Regulatory, and Programming teams to align regulatory deliverables.
qualifications:
- Required:
- MS or PhD in Statistics, Biostatistics, or a quantitative discipline.
- Extensive hands-on experience in statistical review, dataset QC, and troubleshooting SAS statistical programming.
- Advanced knowledge of CDISC standards (SDTM/ADaM) and eCRT submission packages.
- Demonstrated experience managing unblinded clinical trial data and operational boundaries during database lock.
- Preferred:
- Experience supporting NDA submissions and Integrated Summary of Safety (ISS) analyses.
- Therapeutic background in CNS or neurodegenerative diseases.
skills: SAS, ADaM, SDTM, New Drug Application (NDA)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Any consideration of a background check would be an individualized assessment based on the applicant or employee's specific record and the duties and requirements of the specific job.
