Manager, Statistical Programming, SDTM Implementation

Bristol-Myers Squibb - Chicago, IL

Full-time - Mid Level

Chicago, IL

Chemical Manufacturing

About the position

This position provides expertise to drive excellence and consistency in the statistical programming SDTM implementation team at Bristol Myers Squibb. The primary responsibility of this role is to ensure the quality and timely delivery of SDTM artifacts that are essential for downstream activities and regulatory submissions. The successful candidate will be tasked with reviewing study synopses and protocols, providing insightful comments for the Review Committee, and designing SDTM specifications in accordance with the company's CDISC standards. It is crucial that these specifications meet the requirements for downstream ADaM and reporting activities. The role requires a deep understanding of various data collection formats, including CRF and non-CRF (external) data, and the challenges associated with integrating these sources into the target SDTM model. Annotating CRFs and reviewing annotated CRFs in line with BMS guidelines and appropriate metadata is also a key responsibility. The candidate will oversee and develop SAS programs to generate SDTM datasets and create or validate eCRT packages for regulatory submissions. A working knowledge of BMS SDTM automation tools, macros, and metadata is essential. Additionally, the position demands an intricate understanding of the clinical development lifecycle, stakeholder interactions, and data interactions that aid in identifying root causes of issues. Maintaining high quality of deliverables through validation and resolution of issues surfaced in Pinnacle21 and BMS Quality tools is critical to ensure compliance with regulatory submission standards. Collaboration with stakeholders and study team members to manage study timelines, resolve issues, and escalate when necessary is also expected. The candidate will act as a primary point of contact for SDTM programming activities with CROs, ensuring adherence to standards and receiving quality and timely deliverables. Participation in study/project team meetings as a core member to provide technical expertise and support is also part of the role.

Responsibilities

• Provide study SDTM deliverables that support analysis and reporting activities.
• Ensure quality and timely delivery of SDTM artifacts required for downstream activities and regulatory submissions.
• Review synopsis and/or protocol and provide comments for the Review Committee.
• Design SDTM specifications as per Company CDISC standards and ensure they meet downstream ADaM and Reporting requirements.
• Understand different formats of data collection including CRF and non-CRF (external) data and the challenges involved in integration of the two sources into target SDTM model.
• Annotate CRFs and review annotated CRFs in accordance with BMS guidelines and appropriate metadata to reflect tabulation datasets.
• Oversee/develop SAS programs to generate SDTM datasets.
• Create and/or validate eCRT package for regulatory submission.
• Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and BMS Quality tools.
• Collaborate with stakeholders and Study team members to manage study timelines, and resolve issues and escalate if necessary.
• Ensure that all programming deliverables are compliant with CDISC.
• Partner with CROs and act as a primary point of contact for SDTM programming activities.
• Provide oversight of CRO/vendor programming activities to ensure adherence of standards as well as receiving quality and timely deliverables.
• Receive, process and review datasets, as well as data review reports from CROs.
• Ensure that programming best practices are adhered to by both CRO and BMS programmers.
• Participate in study/project team meetings as a core member and provide technical expertise/support.

Requirements

• BA/BS in a relevant scientific discipline such as Life Sciences, Pharmaceutical sciences, Statistics, or Computer science.
• Minimum of 4 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with expertise in CDSIC/SDTM and an end-to-end understanding of the clinical drug development lifecycle.

Benefits

• Competitive benefits and services that provide resources for employees to pursue their goals at work and in their personal lives.