Summary
Overview
Work History
Education
Skills
Timeline
Generic
Tiffany Colacchio

Tiffany Colacchio

Beverly,MA

Summary

Passionate and empathetic professional with nearly 20 years of experience in life sciences. Proficient in areas surrounding diagnostic testing and patient data. Masters in Public Health background with a strong interest in promoting healthy lifestyle factors and in turn preventing disease. Institute of Functional Medicine member and AFMCP candidate committed to a root-cause mindset to restore healthy function and maintain wellness and longevity.

Overview

19
19
years of professional experience

Work History

Principal Analyst, Data Stewardship

Biogen Idec
10.2023 - Current
  • Collaborate with researchers to understand analysis plans to satisfy data sharing requests; Determine pertinent data/documentation and execute coded scripts in SAS; Identify appropriate anonymization level and perform risk analysis; Coordinate anonymization approach across data modalities where appropriate (i.e., tabular, imaging, samples, genetic); Securely deliver data packages adhering to turnaround time; Develop specifications for data re-use and sharing; Lead the management of multiple concurrent requests
  • Contribute to enhancing the data sharing process through the Data X-Ray project by providing support in UAT documentation and brainstorming new ideas for efficiency/improvement; Optimize the end-to-end efficiency of data sharing requests through updates to SAS code, process, and/or upstream data flow; Provide representation on internal/external data sharing forums or committees
  • Lead the Proactive Compatibility Initiative by managing the processing of informed consent forms (ICFs) for data sharing requests; Ingest data/sample/genetic/image determinations into a library to eliminate re-review; Align with Data Privacy/Legal & Compliance to make process improvements; Collaborate with the AI team to enhance artificial intelligence (AI) prompts to extract pertinent information from ICFs

Senior Data Analyst, Data Sharing

Biogen Idec
04.2022 - 10.2023
  • Supported the delivery and oversight of data sharing activities focusing on tabular clinical data anonymization and risk analysis
  • Helped to influence and shape best practices and processes for the inventory and secondary use of clinical data assets

Senior Data Analyst, Data Sciences & Operations

Biogen Idec
10.2019 - 04.2022
  • Supervised/managed data archival for Analytical Data Sciences department; helped to build operational efficiencies; acted as archival SME during audits; supported the creation and enhancement of SOP’s/JA’s
  • Lead the process for eCRF PDF creation, QC, distribution, and receipt within the Medidata portal while building process maps and SOP’s/JA’s

Senior Analyst, Data Quality/External Data & Archiving

Biogen Idec
03.2018 - 10.2019
  • Worked cross-functionally with the Data Standards team to gain exposure to their role and responsibilities
  • Managed data archival of locked Studies for the biometrics department and Worldwide Medical while also working on process improvements (i.e.HP Enterprise eArchival), SOP/JA updates, and external data efforts

Senior Analyst, Data Quality/External Data & Archiving

Biogen Idec
10.2015 - 03.2018
  • Managed data archival of locked Studies (Interim/Final DBL, PDF, Biomarker, eCOA) while also collaborating with IT and other Global Development functions to test and implement new eArchival solution
  • Performed annual user access management review oversight activity for selected studies while maintaining high quality, inspection readiness and efficiency

Senior Analyst III, Statistical Submissions Management

Biogen Idec
06.2013 - 10.2015
  • Worked cross-functionally with the Biostatistics team to gain exposure to their role and responsibilities
  • Involved in roll-out of outsourcing/vendor management activities for submission deliverables
  • Managed the regulatory filing activities for multiple drug programs and provided QC support
  • Lead/supported ongoing efforts to standardize and improve quality and efficiency in submission activities in areas such as: controlled terminology, value-level metadata, SDTM/ADaM standards, define.xml, OpenCDISC, reviewer’s guide, aCRF

Senior Analyst I, Statistical Submissions Management

Biogen Idec
01.2012 - 06.2013

Contract Senior Analyst I, SSM (through Overture Partners)

Biogen Idec
11.2010 - 01.2012
  • Coordinated, prepared, reviewed, and managed Biostatistics electronic submission components for regulatory affairs (FDA and global submissions, Phase 1-3)
  • Adhered to clinical trial/data standards, such as ICH GCP, FDA/PMDA/Health Canada, and CDISC (SDTM, ADaM)
  • Responsible for monitoring and meeting assigned study milestones and requesting resources
  • Lead/supported Statistical Submissions Management or Statistical Programmers staff to accomplish study tasks and communicated issues, as necessary to senior management
  • Provided input to policy, operations and capability building in SPO

Senior Laboratory Operations Assistant

Genzyme Genetics
04.2007 - 11.2010
  • Mentored by lead Biostatician and performed statistical analysis utilizing SAS, MatLab and Excel
  • Implemented Bayesian analysis to calculate the genetic risk of Spinal Muscular Atrophy (SMA)
  • Assumed the Genetic Counselor’s responsibilities in the processing and reporting of EGFR testing
  • Compiled data from clinical trials for analysis
  • Trained new employees and assist in writing workflow SOP’s

Laboratory Operations Assistant, I

Genzyme Genetics
11.2005 - 04.2007
  • Notified directors of inconsistencies and discrepancies in reporting of results
  • Analyzed/Entered reproductive and oncology test results and resolved any discrepancies
  • Maintained data management of patient genetic information for directors and Genetic Counselors
  • Assisted accessioning lab with sample preparation and document imaging
  • Evaluated appropriateness of clinical indications listed on requisition forms
  • Served as the group Safety Representative to adhere to OSHA standards

Education

Applying Functional Medicine in Clinical Practice (AFMCP) -

The Institute for Functional Medicine (IFM)
Federal Way, WA
02.2025

Master of Public Health (MPH) - Biostatistics/Epidemiology

University of Massachusetts Medical School
Worcester, MA
12.2011

Coursework in Biostatistics, SAS Statistical Programming, PH Politics & Policy -

Boston University School of Medicine
Boston, MA
12.2009

Certificate in Biostatistics & Epidemiology -

Drexel University
Philadelphia, PA
08.2008

Certificate in Clinical Genetics -

Brandeis University / Simmons College
Boston, MA
05.2008

Mini Medical School participant (non-credit course) -

Boston University School of Medicine
Boston, MA
05.2006

Bachelor of Science (BS) - Mathematics

Framingham State College
Framingham, MA
05.2005

Skills

  • IFM Member
  • AFMCP candidate
  • Data Privacy
  • Data Anonymization
  • Data Analysis
  • Data Standards
  • Clinical Trial Data
  • Diagnostic Testing
  • Quality Control
  • Flexible and Adaptable
  • Patient and Understanding

Timeline

Principal Analyst, Data Stewardship

Biogen Idec
10.2023 - Current

Senior Data Analyst, Data Sharing

Biogen Idec
04.2022 - 10.2023

Senior Data Analyst, Data Sciences & Operations

Biogen Idec
10.2019 - 04.2022

Senior Analyst, Data Quality/External Data & Archiving

Biogen Idec
03.2018 - 10.2019

Senior Analyst, Data Quality/External Data & Archiving

Biogen Idec
10.2015 - 03.2018

Senior Analyst III, Statistical Submissions Management

Biogen Idec
06.2013 - 10.2015

Senior Analyst I, Statistical Submissions Management

Biogen Idec
01.2012 - 06.2013

Contract Senior Analyst I, SSM (through Overture Partners)

Biogen Idec
11.2010 - 01.2012

Senior Laboratory Operations Assistant

Genzyme Genetics
04.2007 - 11.2010

Laboratory Operations Assistant, I

Genzyme Genetics
11.2005 - 04.2007

Master of Public Health (MPH) - Biostatistics/Epidemiology

University of Massachusetts Medical School

Coursework in Biostatistics, SAS Statistical Programming, PH Politics & Policy -

Boston University School of Medicine

Certificate in Biostatistics & Epidemiology -

Drexel University

Certificate in Clinical Genetics -

Brandeis University / Simmons College

Mini Medical School participant (non-credit course) -

Boston University School of Medicine

Bachelor of Science (BS) - Mathematics

Framingham State College

Applying Functional Medicine in Clinical Practice (AFMCP) -

The Institute for Functional Medicine (IFM)
Tiffany Colacchio