Biostatistics Director Consultant

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...

ClinChoice is currently recruiting for a Biostatistics Director Consultant to join our team.

We are seeking an experienced and highly motivated Biostatistics Director Consultant to provide strategic statistical leadership for clinical development programs across multiple therapeutic areas. The individual will collaborate closely with sponsors, clinical teams, statistical programmers, data management teams, and regulatory stakeholders to ensure high-quality statistical deliverables and successful study execution.

The ideal candidate should possess strong expertise in clinical trial statistics, regulatory submissions, study design, and leadership within a CRO or pharmaceutical environment.

Key Responsibilities

• Provide statistical leadership for Phase I–IV clinical trials across multiple therapeutic areas.
• Lead the development and review of:
  • Statistical Analysis Plans (SAPs)
  • Protocol sections related to statistics
  • Randomization specifications
  • TLF shells and statistical methodologies
• Oversee statistical analyses and interpretation of clinical trial data.
• Collaborate with statistical programming teams to ensure accurate and timely delivery of outputs.
• Support regulatory submissions including NDA, BLA, MAA, and responses to health authority queries.
• Participate in client meetings and provide strategic statistical consultation to sponsors.
• Ensure compliance with ICH-GCP, regulatory guidelines, and company SOPs.
• Mentor and guide junior statisticians and programming teams when required.
• Contribute to proposal development, bid defense meetings, and business growth initiatives.
• Support integrated analyses including ISS/ISE and pooled data reviews.
• Review and approve key study deliverables to maintain quality standards.

Required Qualifications

• Master’s or PhD in Statistics, Biostatistics, Mathematics, or related quantitative discipline.
• Minimum 10–15 years of experience in Biostatistics within CRO, pharmaceutical, or biotech industries.
• Strong knowledge of clinical trial methodology and regulatory requirements.
• Hands-on experience supporting global regulatory submissions.
• Expertise in SAS and understanding of CDISC standards (SDTM/ADaM/TLFs).
• Experience leading sponsor interactions and cross-functional teams.
• Strong communication, leadership, and problem-solving skills.

Preferred Experience

• Experience in Oncology, Immunology, Rare Disease, or Cardiovascular studies preferred.
• Prior experience in client-facing CRO consulting roles.
• Familiarity with adaptive designs and advanced statistical methodologies is an advantage.

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