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Responsibilities
Responsibilities:
- Provide statistical input for protocol development, study design, and sample size calculation.
- Develop statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports.
- Collaborate with cross-functional teams including clinical, regulatory, medical writing, and data management.
- Oversee production and quality control of randomization schedules.
- Review case report forms and data validation guidelines to ensure quality and integrity of study data collection.
- Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards.
- Provide statistical input for Data Safety Monitoring Board (DSMB) and Data Monitoring Committee (DMC) activities, including development of DSMB/DMC charters and analysis plans.
- Serve as an independent statistician providing data and analysis support for DSMB/DMC review.
- Monitor progress on study activities against agreed upon milestones and ensure the study timelines for project deliverables are met.
- Identify out of scope tasks and escalate to management.
- Ensure compliance with regulatory guidelines and industry standards.
- Prepare and review clinical trial reports and regulatory submissions.
- Mentor and provide guidance to junior statisticians, biostatisticians, and statistical programmers.
- Stay updated with advancements in biostatistics and relevant regulatory guidelines.
Qualifications:
- PhD in statistics or biostatistics and 4+ years of experience as a biostatistician in CRO or pharmaceutical companies.
- Master’s degree in biostatistics, statistics, or a related field and 7+ years of experience as a biostatistician in CRO or pharmaceutical companies.
- Thorough knowledge of and experience with CDISC standards, ADaM, and TFL programming.
- Strong proficiency in statistical software (e.g., SAS, R).
- In-depth knowledge in clinical trial methodology and regulatory requirements (e.g., FDA, EMA).
- Excellent problem-solving skills and attention to detail.
- Strong leadership, communication, and interpersonal skills.
- Ability to effectively manage multiple tasks and projects.
- Ability to clearly describe statistical techniques and interpret results.
Indefinitely open
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