Fully Remote
Contract Biostatistician
- Employment Type: Contract or perm
- phase 1 trials
- Location: Fully Remote USA
For Contract Roles Only:
- Hours per week: 20
- Contract duration: 6 months
- Potential to convert to perm: No
- Travel expectations: none
Job Description:
- Provide statistical support for Phase I clinical studies, with a primary focus on descriptive statistical analyses of safety, pharmacokinetic (PK), pharmacodynamic (PD), and biomarker data.
- Develop and review statistical analysis plans (SAPs), tables, listings, and figures (TLFs) in accordance with study objectives and regulatory requirements.
- Perform data review and statistical analyses to support interim analyses, dose-escalation decisions, and final study reporting.
- Collaborate with Clinical Operations, Data Management, Medical Monitoring, and Programming teams to ensure high-quality data and timely study deliverables.
- Contribute to the preparation and review of clinical study reports (CSRs), regulatory submissions, and other study-related documents.
- Provide statistical input on protocol development, study design, and data interpretation.
- Ensure all statistical activities are conducted in compliance with applicable regulatory guidelines, GCP, and company SOPs.
- Perform other biostatistical activities and analyses as requested by the client.
EXPERIENCE, SKILLS & QUALIFICATIONS
- Advanced degree in Statistics, Biostatistics, Mathematics, or a related quantitative field (MS required; PhD preferred).
- Minimum 5 years of biostatistics experience supporting clinical trials within the biotechnology, pharmaceutical, or CRO industry.
- Demonstrated experience supporting Phase I clinical studies, including first-in-human, SAD/MAD, and early development programs.
- Strong knowledge of descriptive statistical methods for safety, PK, PD, and biomarker data analyses.
- Experience developing and reviewing Statistical Analysis Plans (SAPs), Tables, Listings, and Figures (TLFs), and Clinical Study Reports (CSRs).
- Proficiency with statistical software such as SAS.
-Familiarity with CDISC standards (SDTM and ADaM) and regulatory requirements related to clinical trial data analysis. - Ability to interpret and communicate statistical results to cross-functional teams
- Strong understanding of ICH guidelines, GCP, and applicable regulatory requirements.
- Excellent written and verbal communication skills with the ability to work independently in a fast-paced environment.
- Prior experience supporting regulatory submissions and interactions with health authorities is preferred.