Cristina Poletti

EDUCATION and CERTIFICATIONS

Education:

• 2014-2017

Master’s Degree in Statistics, Economics and Business at “Alma Mater Studiorum” (Bologna, Italy)

• 2010-2014

Bachelor’s Degree in Statistical Sciences at University of Turin (Turin, Italy)

Certifications

• SAS Base 9.4

• SAS Enterprise Miner 14

Professional memberships and affiliations:

Italian CDISC UN

WORK HISTORY:Alira Health

Principal Statistical Programmer

Apr 2023 - Present

• Lead statistical programming activities on clinical projects including complex projects

• Provide support in the identification of changes in project scope and potential risks to contractual delivery

• Act as support statistical programmer on clinical projects

• Specify, program and validate CDISC SDTM and ADaM datasets

• Specify, program and validate the statistical analysis results including analysis datasets, tables, listings and figures

• Produce and review CDISC documentation

• Create and validate randomization lists

• Ensure compliance to SOPs

• Report deviations, KPIs, customer complaints and managing CAPAs

• Provide supervision on tasks carried out by statistical programmers

• Provide guidance and mentoring to programming team members on procedures and technical standards

• Prepare and perform internal or external training on statistical programming techniques

• Identify, implement and develop new techniques, solutions, tools and products

• Identify areas for efficiency or process improvement

• Lead internal initiatives to improve department processes

• Communicate effectively with internal and external project teams

• Report issues to Project Manager/Associate Director in an appropriate timeframe

• Support Quality Assurance in internal and external audits

• Support the maintenance of an effective statistical programming department

• Conduct other statistical programming related activities as required

Alira Health

Senior Statistical Programmer

Jan 2020 – Mar 2023

• Act as support statistical programmer on clinical projects

• Act as lead statistical programmer on clinical projects

• Specify, program and validate CDISC SDTM and ADaM datasets

• Specify, program and validate the statistical analysis results including analysis datasets, tables, listings and figures

• Produce and review CDISC documentation

• Create and validate randomization lists

• Ensure compliance to SOPs

• Report deviations, KPIs, customer complaints and managing CAPAs

• Provide supervision on tasks carried out by statistical programmers

• Provide guidance to programming team members on procedures and technical standards

• Prepare and perform internal or external training on statistical programming techniques

• Identify, implement and develop new techniques, solutions, tools and products

• Identify areas for efficiency or process improvement

• Lead internal initiatives to improve department processes

• Communicate effectively with internal and external project teams

• Report issues to Project Manager/Associate Director in an appropriate timeframe

• Support Quality Assurance in internal audits

• Conduct other statistical programming related activities as required

CROS NT

Statistical Programmer

Apr 2016 – Dec 2019

• Development of SAS programs for the statistical analysis of study data finalized to the preparation of tables, listings and figures.

• Programming of analysis datasets.

• Development of SAS programs for the management of clinical study data (i.e. datasets mapping, pooling, import/export, etc.).

Piedmont Region, Torino

Trainee

Jun 2013 – Aug 2013

• Managing Institution’s database, cleaning and checking data.

• Supervising web site.