Job Description
This is a remote position.
The Biostatistician will play a critical role in designing, analyzing, and interpreting clinical trial data to support drug development and regulatory submissions. This position collaborates with clinical, data management, and regulatory teams to ensure statistical rigor in trial design, data analysis, and reporting. The ideal candidate brings strong analytical skills, regulatory knowledge, and proficiency with statistical programming tools.
Key Responsibilities:
Collaborate with clinical and regulatory teams to design statistically sound clinical trials (e.g., sample size calculation, randomization methods).
Develop and review statistical analysis plans (SAPs) in compliance with regulatory guidelines.
Perform statistical analyses using SAS, R, or other statistical software on clinical trial datasets.
Interpret results and present findings in clinical study reports, regulatory submissions, and scientific publications.
Provide statistical support during protocol development, including endpoints and methodology.
Ensure statistical deliverables meet internal quality standards and regulatory requirements (e.g., FDA, EMA, ICH).
Review case report forms (CRFs) and data validation rules for accuracy and consistency with statistical needs.
Collaborate with Data Management and Clinical Operations to ensure data integrity and resolve data discrepancies.
Stay up to date on industry best practices, methodologies, and relevant regulatory guidance.
Minimum Qualifications:
Master’s or Ph.D. in Biostatistics, Statistics, Mathematics, or a related quantitative field.
Minimum of 3 years (for MS) or 1 year (for PhD) of relevant experience in the pharmaceutical, biotechnology, or CRO industry.
Proficient in statistical programming languages such as SAS and/or R.
In-depth knowledge of ICH-GCP, CDISC standards (SDTM, ADaM), and regulatory guidance documents.
Strong understanding of clinical trial design, methodology, and regulatory requirements.
Excellent communication skills with the ability to interpret and present statistical findings clearly.
Strong attention to detail and a commitment to data quality and accuracy.
E-Verify Participation:
Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.
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