Biostatistician Lead Consultant
RemoteUnited States or New England, North Dakota, United States
United States or New England, North Dakota, United StatesRemotePart TimeSenior LevelBiopharmaceuticalSmall
Part TimeSenior LevelSmallBiopharmaceutical
Job Summary
Lead statistical strategy for assigned drug programs, including input to clinical development plans, protocols, SAPs, and regulatory documentation. Accountable for oversight of biostatistics deliverables, randomization procedures, and outsourced CRO activities to ensure high-quality, timely execution. Manage production of planned, post-hoc, and exploratory analyses while supporting novel statistical approaches for rare disease indications. This part-time role requires 20-25 hours per week and reports to the Head of Biometrics.
Required Qualifications
- Ph.D. in Statistics or a related field
- 10 + years of experience in statistical analysis within the biotech/pharmaceutical industry
- Experience with a broad array of statistical approaches
- Experience in proposing novel approaches to support acceleration of clinical programs
- Specifically within rare disease indications
- Solid understanding of regulatory guidelines on drug development
- Solid understanding of regulatory submissions
- Solid understanding of statistical practice
- Strong statistical programming skills (R, SAS, Python)
- Understanding of regulatory guidelines related to submission of datasets using CDISC
- Development of SDTM specifications
- Development of ADaM specifications
- Strong vendor management experience
- Excellent verbal and written communication skills
- Strong attention to detail
- Proactive mindset
- This is a long-term contract position based remotely in the US
- Preference given to local New England based candidates
- This role is for an expected 20-25 hours per week
Desired Qualifications
- Previous experience in Neuromuscular
- Previous experience in Ophthalmology
- Related TA
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