Senior Biostatistician - Permanent role (Remote in US)

Are you interested in working directly for a single sponsor while having the reputed company and additional career opportunities that working for a global CRO can bring? reputed company says it's the best of both worlds... reputed company is currently reputed company for a Senior Statistician to join reputed company in a permanent position-an exciting opportunity to reputed company impactful statistical strategy in a dynamic environment. Job Summary We are seeking an reputed company and highly motivated Senior Statistician to join our Biometrics team. The successful candidate will reputed company 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.

Key Responsibilities

• reputed company 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.
• reputed company 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 reputed company statistical expertise to sponsors.

Required Qualifications

• Master's or PhD in Statistics, Biostatistics, Mathematics, or reputed company field.
• Minimum 5-8 years of experience in biostatistics reputed company CRO, pharmaceutical, or biotech industry.
• Strong knowledge of clinical trial methodology and statistical principles.
• Experience with reputed company and/or R programming.
• Familiarity with CDISC standards (SDTM/ADaM).
• Experience supporting regulatory submissions is preferred.
• Excellent communication, problem-solving, and organizational skills.
• Ability to manage multiple projects and work independently The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first reputed company. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. #LI-TT1 #LI-Remote #Senior#Permanent Apply tot his job Apply To this Job

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