Aleksei Petrov Email & Phone Number

Saint Petersburg, Ru

Санкт-Петербург, Россия

Санкт-Петербург, Санкт-Петербург, Россия

Москва, Россия

• Creation of all structure of Data management and Biostatistical Department, like SOPs, checklists, trackers, templates, macroses• Negotiating with contractors• Interviewing candidates• Manage all timelines of Department• Participation in sponsor audits• Planning budgets of Department

• Act as a lead programmer of indication in Cardiovascular, Renal and Metabolism therapeutic area• Manage all timelines of statistical programming tasks of indication• Coordination all statistical programming aspects of indication• Creating or review all documents of indication• Train employees to CDISC SDTM and ADAM standards• Train employees to best programming practices

• Act as a study lead on:- phases 1-3 of clinical trials in nosologies: oncology, neurology, nephrology, dermatology, rheumatology, orphan diseases.- retrospective study for articles- creation of pooled analysis for CTD, DSUR, RMP, SmPC• Creation of SOPs for Biostatistical Department• Participation in DMC, TSC in role of sponsor biostatistician• Participation in DRM, RBM in role of study lead• Creating and conducting a SAS base course for biostatistics colleagues• Participation in audits in role of study lead and responses to CAPA plan• Calculations of a huge number of different questionnaires for analysis from raw data• Creation of algorithm which calculates the answers of RECIST 1.1 and iRECIST on the basis of tumor dynamics• Review of many clinical study documentation: CRF, DMP, SAP, TFL shells, DTA in the study lead role• Сoordination of the team in unblinding process: communication with unblinded biostatistician of vendor, sending data for unblinding with run instructions• Filing project documentation in sponsors’ and vendors’ TMF• Train employees to CDISC SDTM and ADAM standards• Train employees to SAS Base, Macro, SQL• Creation of many global macros for automatization clinical study report• Develop define.xml and Data Reviewer’s Guides for SDTM and ADaM.• Provide project support to the statistics reporting process through the specification of tables, figures and listings shells, reviewing and writing SDTM and derived (including ADaM) dataset specifications and the formatting of report documents and tabulations.

Saint-Petersburg

• Provide support in creation of new EDC “Clinica”• Train employees to CDISC SDTM and ADAM standards• Train employees to SAS Base, Macro, SQL• Creation a start set of macro on SAS for first project on CDISC standarts• Creation of many global macros for automatization clinical study report• Act as a lead programmer on selected Phase 1-3 projects, and coordinated all programming aspects of the project• Creation of SOPs for Biostatistical Department• Develop, test and run SAS programs for the statistical analysis and reporting of clinical study data. This includes programs for derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings and their validation with using parametric and non-parametric statistical methods such as: ANOVA, RMANOVA, T-Test, Shapiro Wilk, Mann Whitney, Kruskal Wallis, Freedman and other tests• Develop define.xml and Data Reviewer’s Guides for SDTM and ADaM.• Provide project support to the statistics reporting process through the specification of tables, figures and listings shells, reviewing and writing SDTM and derived (including ADaM) dataset specifications and the formatting of report documents and tabulations.

Saint-Petersburg

• Develop, test and run SAS programs for the statistical analysis and reporting of clinical study data. This includes programs for derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings and their validation.• Develop define.xml and Data Reviewer’s Guides for SDTM and ADaM.• Ensure the maintenance of documentation e.g. the description of programs and validation.• Produce ad hoc data summaries when requested during the course of a trial. • Liaise with internal departments, sponsors and other third parties to ensure all delivery requirements fulfil client needs. • Act as a lead programmer on selected Phase 1 projects, and coordinated all programming aspects of the project.• Provide project support to the statistics reporting process through the specification of tables, figures and listings shells, reviewing and writing SDTM and derived (including ADaM) dataset specifications and the formatting of report documents and tabulations.• Act as a trainer and mentor for assistant statistical programmers. Involved in the planning and development of the trainings provided for new staff.• Provide support in process improvements, and to develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting. • Maintain a high level of expertise in SAS applications, Good Clinical Practice, clinical/ statistical reporting and regulatory submission requirements.• Perform all activities in compliance with WCT and agreed sponsor quality system standards, relevant GCP standards and specifically with FDA Quality System Regulation (including 21CFR Part 11).