Senior Biostatistician

Palo Alto, CA - USA

Hourly Salary: $ 110 - 115

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Description

Contact: Neisha Camacho/Terra Parsons -
No 3rd party candidates

On-Site - Candidates must be local to Palo Alto

We are seeking an experienced and strategic Senior Biostatistician to lead biostatistical support across our clinical development programs and regulatory submissions. This role will provide scientific and operational oversight across all phases of clinical trials ensuring rigorous statistical methodology data integrity and regulatory compliance. The ideal candidate is both technically strong and a collaborative leader with a proven track record of guiding cross-functional teams through global regulatory engagements (e.g. FDA EMA).

Key Responsibilities

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

Job DescriptionContact: Neisha Camacho/Terra Parsons - No 3rd party candidatesOn-Site - Candidates must be local to Palo AltoWe are seeking an experienced and strategic Senior Biostatistician to lead biostatistical support across our clinical development programs and regulatory submissions. This rol...