Senior Biostatistician

3 weeks ago

India Unicon Pharma Inc Full time

Title: Senior Biostatistician

Location: Remote/ Bangalore, India

Contract: 3 Months


Primary Purpose

Leads collaborations with clinical investigators to determine study design, contributes to protocol development, authors statistical analysis plans, performs statistical analysis, makes statistical inference and writes and presents reports summarizing findings including publications in peer-reviewed journals. Manages statistical activities for a clinical study or platform of clinical studies.


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 EMMES 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.


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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