Senior Biostatistician

  • Location

    North Carolina, USA

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Jessica Charles

  • Contact email:

    Jessica.Charles@volt.eu.com

  • Job ref:

    78427-PHARM-JCH_1619597988

  • Published:

    3 months ago

  • Expiry date:

    2021-06-27

  • Startdate:

    01/02/21

My client is a full-service CRO with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the market.



They're looking for a Senior Biostatistician to join their team and provide lead statistical support and oversight in the project specific creation of SAP, ADaM dataset specifications, and the execution and QC of clinical trial analyses.



Responsibilities:

Leading and/or supporting the planning, management, and execution of statistical and statistical programming activities for clinical trials, patient registries, and other activities as requested by clients
Providing sound statistical input on study/research design to meet project needs, regulatory and scientific requirements, including all statistical deliverables for clinical trials
Successfully represent the department and the company in client meetings/presentations and maintain a positive working relationship with sponsors, collaborating associates, and vendor personnel
Identify project priorities and project timeline goals and communicate priority-related issues and timelines to programming and support teams
Provide biometrics leadership and coordination across client and other vendor functional areas, including clinical operations, data management, regulatory, and medical writing teams
Manage project budgets, support financial reporting for studies, identify of out of scope work


Qualifications:

MSc/PhD in Statistics or related field.
4+ years relevant experience in clinical research.
Experience using SAS
CDISC experience preferred (specifically ADaM specifications and submission document input/reviews)