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, WA02.2025
Master of Public Health (MPH) - Biostatistics/Epidemiology
University of Massachusetts Medical School
Worcester, MA12.2011
Coursework in Biostatistics, SAS Statistical Programming, PH Politics & Policy -
Boston University School of Medicine
Boston, MA12.2009
Certificate in Biostatistics & Epidemiology -
Drexel University
Philadelphia, PA08.2008
Certificate in Clinical Genetics -
Brandeis University / Simmons College
Boston, MA05.2008
Mini Medical School participant (non-credit course) -
Boston University School of Medicine
Boston, MA05.2006
Bachelor of Science (BS) - Mathematics
Framingham State College
Framingham, MA05.2005
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)
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