Principal Biostatistician, Late Phase
New
Fully remote, home-based work opportunity within the United States.Full-TimePrincipal
Salary115,900 - 243,900 USD per year
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Job Details
- Experience
- PhD with at least 5 years of experience; Master's degree with at least 7 years of experience; minimum 3 years of experience supporting Phase II/III clinical trials.
- Required Skills
- R
Requirements
- PhD in Statistics, Biostatistics, or related field with 5+ years experience.
- Master’s degree with at least 7 years of industry experience.
- Minimum 3 years of experience supporting Phase II and/or Phase III clinical trials.
- Strong expertise in statistical methodologies for clinical research.
- Proficiency in SAS and/or R.
- Experience with ADaM datasets and TLF development.
- Solid knowledge of CDISC standards (SDTM, ADaM, CDASH).
- Understanding of ICH E9, ICH GCP, and regulatory requirements.
- Experience with multiple imputation and advanced statistical techniques.
- Excellent communication and collaboration skills.
Responsibilities
- Provide statistical leadership and support for Phase II and Phase III clinical trials.
- Collaborate with cross-functional teams to establish study objectives and analysis strategies.
- Author and review Statistical Analysis Plans (SAPs), analysis dataset specifications, and TLF documentation.
- Perform and oversee efficacy and safety analyses using SAS or R.
- Guide and support statistical programmers in the development and validation of deliverables.
- Interpret clinical study results and contribute to regulatory submissions.
- Support exploratory analyses and provide statistical consultation to clinical teams.
- Participate in regulatory activities including INDs, NDAs, and briefing documents.
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