Overview

Reporting to the Chief Scientific Officer, the successful candidate will serve an overarching role to position Biostatistics and Statistical Programming as a well-coordinated and innovative function at ClinSoft, ensuring strategic planning and close cross-functional communication to drive programs forward.

Responsibilities:

  • Initiate research studies and approve statistical methodologies for analysing data;
  • Develop and use statistical programs for data analysis to transfer theoretical statistical concepts into computationally programming codes;
  • Apply and develop hypothesis testing methods, conduct regression analysis and build statistical models to meet the objectives of the studies;
  • Ensure effective implementation of model development, maintenance and update processes;
  • Ensure accuracy of results and analytic methods and perform regular validation and collaborations of the analytical models;
  • Use advanced data visualization techniques to represent the findings;
  • Develop  automated and reproducible solutions and validated statistical programs;
  • Contribute to database design, implementation and maintenance of data collected over time for research purposes, including acquisition, editing and reporting;
  • Lead the process of Statistical Analysis Plans (SAPs) development;
  • Check and approve the mocks and shells for final Tables, Listings and Figures (TLFs);
  • Conduct quality control by acting as an independent reviewer;
  • Manage the process of results interpretation, reports generation and preparation of tables and figures for publications and presentations;
  • Review reports and TLFs to ensure quality and accuracy;
  • Ensure adherence to industry regulatory requirements,  standard operating procedures (SOPs) and project specific guidelines;
  • Develop operational procedures for collection, editing, verification, and management of statistical data and maintain documentation of process for quality assurance and reporting;
  • Define, develop and communicate new standards and best practices;
  • Provide mentorship and share knowledge with departmental functional and other department team members;
  • Maintain compliance with all Company policies and procedures;
  • Perform other job-related duties as assigned by Head of Department and/or Chief Scientific Officer (CSO).

Required Qualifications:

  • University degree in Statistics, Biostatistics, Data Science, Mathematics, Computer Sciences, Economics or a related field; PhD degree is preferred; 
  • At least 5 years of experience in relevant field;
  • Experience with statistical analysis and modeling; experience in advanced regression analysis, mixed-effect modelling, non-linear modelling, survival analysis, and Bayesian statistics is a plus;
  • Extensive experience (minimum 2 years) in R and/or Python programming languages;
  • Experience with R Markdown, knitR or LaTex is preferred;
  • Experience with large administrative databases such as healthcare claims survey or personnel data is preferred;
  • Experience with Git is preferred;
  • GCP certificate is preferred; 
  • Excellent knowledge of English language;
  • Excellent interpersonal and communication skills;
  • Exceptional organizational skills with a keen eye for detail and accuracy along with  superb data documentation skills;
  • Exceptional time management skills and ability to effectively prioritize and manage multiple projects and tight deadlines.

About ClinSoft LLC

ClinSoft LLC is an IT-based company which implements the projects of EMMES Corporation. For more information about the Company and the projects it develops, please visit: www.emmes.com.