Lead/Principal Statistician Consultant-Medical Affairs (remote)

ClinChoice; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

ClinChoice is seeking a Lead/Principal Statistician Consultant for their Medical Affairs team. This remote position involves leading biostatistical efforts in post-marketing studies and real-world evidence, requiring extensive experience in biostatistics and clinical research. The ideal candidate will guide cross-functional teams and ensure compliance with regulatory standards while mentoring junior staff.

Qualifications

• 8+ years (PhD) or 10+ years (Master’s) in pharma, biotech, or CRO sectors.
• Experience in Medical Affairs, post-marketing, or RWE studies.
• Knowledge of GCP, ICH, and regulatory frameworks.

Responsibilities

• Lead biostatistics for Medical Affairs projects.
• Design studies, develop protocols, and analysis plans.
• Collaborate with Medical Affairs, HEOR, and Regulatory teams.

Skills

Biostatistics

Clinical Research

Communication

SAS

R

Education

Ph.D. or Master’s in Biostatistics, Statistics, or related field

Job description

Lead/Principal Statistician Consultant-Medical Affairs (remote)

Join to apply for the Lead/Principal Statistician Consultant-Medical Affairs (remote) role at ClinChoice.

Position Overview

ClinChoice is seeking a highly experienced Principal Biostatistician to support our Client Medical Affairs team. This role offers statistical leadership, strategic input, and operational support across post-marketing studies, real-world evidence (RWE), and other medical initiatives. The ideal candidate will have a strong biostatistics background, clinical research understanding, and experience supporting cross-functional teams in pharma or biotech environments.

Key Responsibilities

1. Lead biostatistics for Medical Affairs projects, including Phase IV, observational studies, registries, and RWE analyses.
2. Design studies, develop protocols, analysis plans, and reporting documentation.
3. Collaborate with Medical Affairs, HEOR, Clinical Development, Data Management, and Regulatory teams.
4. Guide scientific publications, conference presentations, and regulatory submissions.
5. Oversee statistical deliverables from CROs/external vendors ensuring quality and compliance.
6. Develop and review SAPs, table shells, and related documents.
7. Ensure adherence to ICH guidelines, regulatory standards, and SOPs.
8. Mentor junior statisticians and provide technical guidance.
9. Support audits and inspections as needed.

Required Qualifications

• Ph.D. or Master’s in Biostatistics, Statistics, or related field.
• 8+ years (PhD) or 10+ years (Master’s) in pharma, biotech, or CRO sectors.
• Experience in Medical Affairs, post-marketing, or RWE studies.
• Proficiency in SAS and/or R.
• Knowledge of GCP, ICH, and regulatory frameworks.
• Ability to communicate complex concepts effectively.
• Experience with publication planning is a plus.

Preferred Qualifications

• Experience in oncology, immunology, neurology, or similar fields.
• Familiarity with claims data, EHRs, or registries.
• Experience managing CROs or external vendors.

Application Process

Submit your CV to receive acknowledgment. Qualified candidates will be invited for a phone interview. Due to high application volume, individual responses may not be provided.

About ClinChoice

ClinChoice is a global CRO with over 28 years of experience, 4,000+ professionals across 20+ countries, dedicated to quality and innovation in clinical development.

Our mission is to contribute to a healthier world by accelerating drug and device development. We value diversity and inclusivity, fostering a supportive environment for all employees.