Senior Biostatistician - Permanent role (Remote in US)
About The Position
ClinChoice is currently recruiting for a Senior Statistician to join our team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment. We are seeking an experienced and highly motivated Senior Statistician to join our Biometrics team. The successful candidate will provide statistical support for clinical trials across multiple therapeutic areas and contribute to study design, protocol development, statistical analysis, and regulatory submissions. This role requires strong technical expertise, excellent communication skills, and the ability to collaborate with cross-functional teams in a fast-paced CRO environment.
Requirements
- Master’s or PhD in Statistics, Biostatistics, Mathematics, or related field.
- Minimum 5–8 years of experience in biostatistics within CRO, pharmaceutical, or biotech industry.
- Strong knowledge of clinical trial methodology and statistical principles.
- Experience with SAS and/or R programming.
- Familiarity with CDISC standards (SDTM/ADaM).
- Excellent communication, problem-solving, and organizational skills.
- Ability to manage multiple projects and work independently
Nice To Haves
- Experience supporting regulatory submissions is preferred.
Responsibilities
- Provide statistical support for Phase I–IV clinical trials.
- Participate in protocol development, study design, and sample size calculations.
- Prepare and review Statistical Analysis Plans (SAPs), TLF shells, and randomization specifications.
- Perform statistical analyses and interpret study results.
- Collaborate with Clinical Data Management, Statistical Programming, Medical Writing, and Clinical Operations teams.
- Review outputs, tables, listings, and figures for accuracy and consistency.
- Support regulatory submissions including ISS/ISE and responses to health authority queries.
- Ensure compliance with CDISC, ICH-GCP, and regulatory guidelines.
- Contribute to process improvements and mentoring of junior statisticians.
- Participate in client meetings and provide statistical expertise to sponsors.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
