Senior Biostatistician Job Description

The Biostatistician, Senior prepares analysis plans to ensure the best statistical methods are developed and utilized. Conducts statistical studies to generate data and insights used to innovate, plan and support improved healthcare outcomes and processes. Being a Biostatistician, Senior interprets analyses and prepares exhibits for reports and presentations. Writes specifications for files, consistency checks, tables, and calculations used to collect and analyzes data from a variety of sources. In addition, Biostatistician, Senior interfaces with non technical users to assist with data interpretation and understanding of results. Proficient with statistical computer applications like SAS and R. Requires a master’s degree of biostatistics, statistics, mathematics or related field. Typically reports to a manager or head of a unit/department. Being a Biostatistician, Senior work is generally independent and collaborative in nature. Contributes to moderately complex aspects of a project. Working as a Biostatistician, Senior typically requires 4 -7 years of related experience.

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Senior Biostatistician Job Description Template

Our company is looking for a Senior Biostatistician to join our team.

Responsibilities:

  • Develops statistical programs as necessary to perform analyses and prepare data displays;
  • Participate in developing the case report form (CRF);
  • Provide statistical support to clinical team, study projects, and data management;
  • Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems;
  • Code complex statistical analyses as needed;
  • Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors;
  • Develop SAP and create table, listing, and figure shells;
  • Review programming specifications and derived datasets;
  • Perform duties of a study statistician to support clinical trials. Oversee statistical aspects in the design of clinical trials;
  • Provide statistical support to assist with sample size and data analyses for clinical trials;
  • Participate in development of the statistical analysis plan (SAP) for a clinical studies and execute SAP throughout lifecycle of the study;
  • Design experiments for assay development, troubleshooting, research and process capability;
  • Performs statistical analysis and interpretation of data for projects and research grants;
  • Work independently with various internal customers;
  • May assist and train users on computer programs.

Requirements:

  • Demonstrated initiative and motivation;
  • Excellent written and verbal communication skills;
  • Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required;
  • Knowledge of FDA regulations, ICH GCP guidelines, the drug development process;
  • Able to prioritize work and complete deliverables to timelines with limited supervision;
  • Master degree in statistics with 4 years experiences;
  • Good organizational skills, with the ability to adapt and adjust to changing priorities;
  • PhD in statistics with 2 years experiences;
  • Working knowledge of clinical trial design;
  • Detail and process oriented;
  • Strong SAS programming skills;
  • Statistical Programming Capability (SAS and R);
  • Pharmaceutical/GMP experiences;
  • Effective oral and written communication skills for interactions with non-statistician functions.