Senior Biostatistician
Senior Biostatistician
Posted on :
22-09-2025
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1 Vacancy
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Job Description
Job Description
- Provide statistical leadership across clinical development programs including study design protocol development SAP creation and analysis planning.
- Oversee statistical deliverables for clinical trials from early phase through late-stage development and regulatory submission.
- Partner with Clinical Regulatory Data Management and Medical Writing teams to ensure statistically sound study design and high-quality deliverables.
- Lead the development and review of key documents including statistical analysis plans clinical study reports and regulatory filings (e.g. NDA BLA MAA).
- Represent biostatistics in interactions with regulatory agencies including preparing responses and meeting participation.
- Manage external CROs/consultants to ensure on-time high-quality statistical support and deliverables.
- Drive process improvements innovation and adoption of best practices in statistical analysis and data visualization.
- Ensure compliance with industry and regulatory standards including ICH GCP FDA EMA and CDISC.
Education & Qualifications
- PhD or Masters in Biostatistics Statistics or a related quantitative field.
- 10 years of experience in biostatistics within the pharmaceutical biotech or CRO industry including expertise in late-phase clinical trials and regulatory submissions.
- Proven experience leading teams and managing complex clinical development programs.
- Strong knowledge of statistical methods for clinical trials regulatory guidelines and CDISC standards (SDTM ADaM).
- Proficiency in statistical software (e.g. SAS R).
- Excellent communication leadership and project management skills.
- Experience with global regulatory interactions and submissions preferred.
$110-$115 hourly W2 / $135-$140 hourly 1099 commensurate with experience
Required Experience:
Senior IC
Employment Type
Contract
Key Skills
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