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Senior Biostatistician
ACL Digital
Chennai, KSA
Full Time
Senior
Hybrid
3 weeks ago
SASRCDISCADaMClinical Trial DesignStatistical Analysis Plan
Free
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SASRCDISC
About the Role
ACL Digital seeks a Senior Biostatistician with biomarker experience for a hybrid/remote role across India. The position involves providing statistical input for protocol development, developing SAPs, overseeing randomization, and ensuring compliance with regulatory guidelines.
Key Skills for This Role
SASRCDISCADaMClinical Trial DesignStatistical Analysis Plan
Responsibilities
- Provide statistical input for protocol development, study design, and sample size calculation
- Develop Statistical Analysis Plan including definition of derived data and design of statistical tables, figures, and data listings
- 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 SAP and CDISC ADaM standards
- Provide statistical input for DSMB/DMC activities, including development of charters and analysis plans
- Monitor progress on study activities against milestones and ensure timelines are met
- Prepare and review clinical trial reports and regulatory submissions
- Mentor and provide guidance to junior statisticians and statistical programmers
- Stay updated with advancements in biostatistics and relevant regulatory guidelines
Requirements
- PhD in statistics or biostatistics with 4+ years of experience as a biostatistician in CRO or pharmaceutical companies, or Master's degree in biostatistics/statistics with 7+ years of experience
- Thorough knowledge of CDISC standards, ADaM, and TFL programming
- Strong proficiency in statistical software (e.g., SAS, R)
- In depth knowledge of 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
Full Job Posting
Job Description
- Provide statistical input for protocol development, study design, and sample size calculation.
- Develop Statistical Analysis Plan 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)/Data Monitoring Committee (DMC) activities.
- Monitor progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.
- Ensure compliance with regulatory guidelines and industry standards.
- Prepare and review clinical trial reports, and regulatory submissions.
- Mentor and provide guidance to junior statistician or biostatistician and statistical programmer.
- 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 or Master’s degree in Biostatistics or statistics, or 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 requirement (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.
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