Senior Bio Statistician-R programming:-ADaM,ANOVA, ANCOVA

17 hours ago

Chennai, Tamil Nadu, India Cortex Consultants Full time ₹ 12,00,000 - ₹ 36,00,000 per year
Overview The Senior Biostatistician plays a pivotal role in the research and development of clinical projects by applying statistical methods and providing insights through data analysis. This position requires expertise in R programming and a deep understanding of statistical techniques such as Analysis of Variance (ANOVA) and Analysis of Covariance (ANCOVA). The Senior Biostatistician will not only collaborate with various teams to ensure compliance with regulatory standards but also contribute to the development of statistical analysis plans and the interpretation of results. Given the importance of accurate statistical evaluations in clinical trials, this role is critical to the decision-making processes that impact patient outcomes and the overall success of pharmaceutical developments. You will lead projects and mentor junior biostatisticians, making your contribution vital to enhancing the organization's capabilities and ensuring the integrity of research findings. Key Responsibilities
  • Develop and implement statistical analysis plans for clinical studies.
  • Perform statistical analyses using R, focusing on ADaM, ANOVA, and ANCOVA methodologies.
  • Collaborate with clinical research teams to define analysis objectives and timelines.
  • Create and validate datasets to ensure accuracy and compliance with regulatory standards.
  • Generate and interpret statistical results to contribute to clinical study reports.
  • Work closely with data managers to design data collection tools and processes.
  • Conduct exploratory data analyses and prepare visualizations to communicate findings effectively.
  • Participate in protocol development and provide statistical input on study design.
  • Mentor and supervise junior statisticians and biostatisticians.
  • Conduct peer reviews of statistical analyses and reports executed by peers.
  • Stay current with biostatistics trends, methodologies, and regulatory guidance.
  • Present statistical findings to stakeholders and at scientific meetings.
  • Assist in regulatory submissions by preparing statistical sections of FDA submissions and other documents.
  • Participate in interdisciplinary project meetings and collaborate with cross-functional teams.
  • Continuously improve statistical practices and methodologies within the team.
Required Qualifications
  • Master's or PhD in Biostatistics, Statistics, or related field.
  • Minimum of 5 years of experience in a biostatistical role within the pharmaceutical or biotechnology industry.
  • Proficiency in R programming for statistical computing and data visualization.
  • Experience with ADaM data standards and regulatory guidelines.
  • Strong knowledge of ANOVA, ANCOVA, and other statistical methodologies.
  • Excellent understanding of clinical trial design and regulatory requirements.
  • Proficiency in other statistical software such as SAS is highly desirable.
  • Exceptional analytical and problem-solving skills.
  • Ability to communicate complex statistical concepts to non-statistical audiences.
  • Experience in leading statistical analyses for multiple clinical projects simultaneously.
  • Strong attention to detail and commitment to data integrity.
  • Demonstrated ability to work collaboratively within a team environment.
  • Experience mentoring or training junior staff members.
  • Published research or contributions to scientific literature is a plus.
  • Excellent organizational and time management skills.
  • Strong interpersonal skills and ability to work in a diverse environment.

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