Bylaws

1. The Name of the Section

ISBA Section on Biostatistics and Pharmaceutical Statistics (ISBA/Biostat&Pharma).

2. The Purpose of the Section

The primary purpose of the Section is to promote the research, application and dissemination of Bayesian methods and solutions for problems in Biostatistics and Pharmaceutical statistics. This covers the many facets of biostatistics, and statistics applied to medicine comprising both the clinical and non-clinical aspects of pharmaceutical statistics. It includes, non exhaustively, optimal design and analysis of clinical trials (drugs, biologics, and medical devices), Bayesian adaptive trial designs, medical decision making, Benefit: risk assessment for regulatory decision making, model-based drug development (pharmacokinetics / pharmacodynamics / pharmacogenetics), biostatistics, bioinformatics and its applications to genetics, genomics and proteomics, and pharmacoeconomics. In order to achieve this purpose, the section activities consist of:

  • Promoting education and use of Bayesian methods in Biostatistics and Pharmaceutical statistics by developing workshops, courses and webinars for students and practitioners
  • Organizing short courses, workshops, conferences, webinars and sessions within ISBA meetings
  • Promoting interactions among academia, regulatory agencies and industry
  • Promoting interactions and outreach to pharma, medical device, and clinical trial professionals, with a focus on exploring how Bayesian statistics can solve their problems and fit their specific needs
  • Connecting and bringing visibility to initiatives from academia, regulatory agencies and industry aimed at spreading Bayesian methods and ideas, by federating them under a common brand
  • Fostering faster/easier availability of Bayesian methods , via devepment of software packages and publication in field-specific journals

3. The Offices, Duties, and Terms of Offices

The offices are those of Chair, Chair-elect, Program chair, Treasurer, and Secretary. The Chair-elect, Program chair, Treasurer, and Secretary are elected by the membership for staggered two year terms. The Chair-elect succeeds the office of Chair for a term of two years. The elected officers constitute the ISBA/Biostat & Pharma Executive Committee, which shall follow the general policies established by the ISBA Board and shall conduct the affairs of the section between meetings of the Board. The ISBA/Biostat & Pharma Executive Committee shall report to the Board at each Board meeting. The report can be in writing. The Section Chair convenes and chairs meetings of the ISBA/Biostat & Pharma Executive Committee and the Section membership. The duties of the Secretary, Treasurer and the Program Chair are as described in item 4.B through D of the ISBA constitution, but restricted to the Section. The Secretary will also act as the webmaster for the Section. The Program Chair additionally works, with the other members of the Executive Committee, to organize conferences, workshops, and short courses. The right to enter into legal contracts for ISBA or ISBA/Biostat & Pharma is vested solely in the ISBA Executive Committee.

4. Addiotional Provisions for Elections of Section Officers

Each year a five-member Nominating Committee will nominate candidates for Section offices. Three members of the Committee will be elected by the Executive Committee based on suggestions from the Section membership. To facilitate this process, for every election year, the Section Chair will request suggestions from the Section members. The Executive Committee will elect three members from the suggested names and appoint one of the three members as Chair of the Nominating Committee. The remaining two positions in the committee will be filled by the two current officers who will be replaced in the upcoming election. The Nominating Committee selects and gets consent to stand for election from, at least two candidates for each office. The term for all officers starts on January 1 following the election.

5. Section Memberships

Any ISBA member who pays the Section membership fee is a member of the section. The Section membership fee is set by Biostat & Pharma Executive Committee and approved by the ISBA Board by resolution.

6. Annual Reports

The Secretary will be responsible for submitting all Section reports, including annual reports of Section activities to the ISBA Board.