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Lead/Principal Statistician Consultant-Medical Affairs (remote)

Lead/Principal Statistician Consultant-Medical Affairs, statistical leadership in post-marketing studies.
ClinChoice
Remote
United States
Undisclosed salary
Job Description
ClinChoice is seeking a highly experienced Principal Biostatistician Consultant to support a client's Medical Affairs team. This role provides statistical leadership, strategic input, and operational support across post-marketing studies, real-world evidence (RWE), and other medical affairs initiatives. The ideal candidate will have a strong background in biostatistics and clinical research, with hands-on experience supporting cross-functional teams in a pharmaceutical or biotech environment.

Role involves:
  • Serving as the lead biostatistician for Medical Affairs projects.
  • Providing statistical expertise in study design, protocol development, analysis planning, and reporting.
  • Collaborating with cross-functional teams.
  • Guiding the statistical aspects of scientific publications, conference presentations, and regulatory submissions.
  • Overseeing statistical deliverables from CROs or external partners.
  • Developing and reviewing statistical analysis plans (SAPs), table shells, and other relevant documentation.
  • Ensuring adherence to ICH guidelines, regulatory requirements, and internal SOPs.
  • Mentoring junior biostatisticians and providing technical guidance.
  • Supporting audits and inspections by regulatory bodies.

Requirements:
  • Ph.D. or Master’s degree in Biostatistics, Statistics, or a related quantitative field.
  • Minimum of 8+ years (PhD) or 10+ years (Master’s) of experience in the pharmaceutical, biotech, or CRO industry.
  • Strong experience in Medical Affairs, post-marketing studies, or real-world data (RWD)/real-world evidence (RWE).
  • Proficiency in SAS and/or R for statistical programming and analysis.
  • In-depth knowledge of GCP, ICH guidelines, and relevant regulatory frameworks.
  • Proven ability to collaborate effectively across functional areas and communicate complex statistical concepts to non-statistical audiences.
  • Experience with publication planning and manuscript development is a strong plus.

ClinChoice offers:
  • Opportunity to work directly for a single sponsor while having the security and career opportunities of a global CRO.
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ClinChoice

ClinChoice is a global provider of regulatory and scientific services, specializing in preparing and submitting compliant Material Safety Data Sheets (MSDS/SDS). The company supports multinational chemical manufacturing companies, offering hazard analysis, SDS authoring, and regulatory compliance expertise across US, EU, and other international markets. ClinChoice focuses on establishing structured processes for SDS preparation, and delivers comprehensive hazard assessments and SDS phrases based on global regulatory standards. They provide mentorship and review services.

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