Biostatistician
P
Pharmavise Consulting CorporationPharmaceutical, Biotechnology
United StatesContractMiddle
Salary not disclosed
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Job Details
- Experience
- Minimum of 3 years (for MS) or 1 year (for PhD) of relevant experience in the pharmaceutical, biotechnology, or CRO industry.
- Required Skills
- R
Requirements
- 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.
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.
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