Janet J. Li, Aakar Shah Pfizer Inc. Something Old, Something New: A little programming management can go a long way Janet J. Li, Aakar Shah Pfizer Inc.

Have you ever been in Benjamin’s, Emma’s, or Olivia’s shoes? Benjamin has been frantically searching for the most up-to-date version of his study’s SDTM and ADaM datasets. The previous study lead has already left the organization, so he can’t ask him for the whereabouts. Emma is a statistical programming manager who wished she had easier access to the status of the projects that her direct report lead Olivia is the director of statistical programming in her organization and she wishes for a high-level summary of the studies that fall under her umbrella

Project management and tracking tool Allow us to manage ourselves, others, deliverables, and timelines at study level A summary of study highlights can be pulled from individual study tracker files and be presented as an aggregate report to upper management

Study Tracker Tool Study team contact information Study files management Study highlights and deliverables Ongoing Completed Future Risk management

Study team contact information

Study files management In the highlighted example, “Study_01_SDRG” is hyperlinked to the Study 01 SDTM Reviewer’s Guide file pathname and we can see that the most current version of the SDTM Reviewer’s Guide is a draft from December 1, 2017.

Study Highlights and Deliverables

Risk Management The above table details a qualitative risk register for Study 04 Risk: identified risks are described Impact: consequence of the risk (“critical”, “high”, “medium”, “low”) Probability: likelihood of the occurrence of risk (“high”, “medium”, “low”) Risk Mitigating Actions: responses to the occurrence of the risk

Management Summary High-level summary of study highlights from the individual study tracker files Can be presented as aggregate report to upper management Built according to needs of organization/team

Aggregate Study Highlights and Timelines

Aggregate Study Highlights and Timelines We used the HIGHLOW plot statement (SG procedures, GTL) to create the aggregate study highlights and timelines Use the HIGHLOW parameter y instead of x to create the horizontal bar segments seen in the aggregate highlights & timelines report

Aggregate Risk Summary Report Overview of the risks for all studies (can be built to only show the risks that have high or critical impact as seen in the table)

Conclusion Successful implementation of this proposed project management tool The tool should be reviewed and updated on a regular basis as new information becomes available Can be updated to fit the needs of any statistical programming organization or team

Contact Information Name: Janet J. Li Company: Pfizer Inc. City/State: San Francisco, CA Email: JANET.LI@Pfizer.com Name: Aakar Shah Company: Pfizer Inc. City/State: San Francisco, CA Email: AAKAR.SHAH@Pfizer.com