Senior Biostatistician

2 days ago

Bengaluru, Karnataka, India Unicon Pharma Inc Full time

Responsibilities

  • May supervise Biostatisticians, Associate Biostatisticians and SAS programmers (all levels) and direct their work on clinical research studies.
  • Provides expert consultation to projects across the company on statistical methodology.
  • Solves problems of complex statistical scope.
  • Provides technical review of proposed statistical design for research studies across company.
  • Serves as the lead Biostatistician on one or more study projects.
  • Participates in statistical process development and improvement across company.
  • May present at statistical conferences.
  • Provides sound strategic, scientific and statistical input to support client's research projects.
  • Leads the project team's development of study analysis plans and statistical programs to perform analyses and display study data.
  • Keeps abreast with current statistical and medical literature to ensure that sound methodologies are adopted.
  • Fosters innovation in Biostatistics that will continuously enhance current statistical knowledge and practices.
  • Ensures the scientific integrity of the research project and the accuracy of the reported results.
  • Performs sample size calculation and provides leadership in the statistical design of research projects.
  • Reviews protocols and case report forms to ensure that protocol objectives are met, and standards are maintained.
  • Develops study assignment allocation schemas along with appropriate documentation.
  • Leads the development of the methods and results sections of clinical study reports and scientific publications.
  • Represents Client on behalf of clients at regulatory meetings.
  • Provides expertise in methodological advances both internally and externally to improve statistical methodologies.
  • Participate in the development and updating of Standard Operating Procedures.
  • Other duties as assigned

Qualifications

  • MS in biostatistics, statistics, or PhD in biostatistics, statistics, epidemiology or related field
  • At least 4 years of related experience with MS or 1 year of related experience with PhD is expected but not required.
  • Experience with methodological statistical research, including publication and/or presentation of work in statistical methods development.
  • Demonstrated proficiency with statistical methods and applications in clinical research.
  • Strong programming skills in SAS and/or R.
  • Expertise in state-of-the-art data manipulation and statistical methodology.
  • Excellent communication, interpersonal and organization skills.
  • Ability to manage multiple tasks.
  • Ability to work independently, as well as in a team environment.
  • Ability to effectively communicate complex statistical concepts, both written and oral.

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