Manager, SDTM Statistical Programming

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The SDTM Implementation Team is responsible for the implementation, of organizational SDTM standards and generate SDTM package for stakeholder consumption and regulatory submissions. The infrastructure includes comprehensive mapping specifications, macros and eCRT submission packages. The team also contrinutes to the development of standard global and Therapeutic area CRFs also leads the professionalization of SDTM standards expertise across the organization through structured training, deep standards education, and hands‑on implementation support to the study team to ensure consistent, high‑quality SDTM delivery.

The Manager, SDTM, Statistical Programming provides expertise to drive excellence and consistency in statistical programming SDTM implementation team.  Primarily, this position is responsible for providing study SDTM deliverables that support analysis and reporting activities. 

Responsibilities:

• Primarily responsible for 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 specification as per company and industry 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.

• Working knowledge of BMS SDTM automation tools, macros and metadata.

• Familiarity with the latest developments in the industry regarding automation and AI particularly in the context of SDTM deliverables.

• Intricate understanding of clinical development life-cycle, stake-holder interactions and data interactions that aid in identification of issues root-cause.

• Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and BMS Quality tools and ensure the quality meets regulatory submission standards.

• 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 standards requirement.

• 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

Degree Requirements:

• BA/BS in a relevant scientific discipline

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Experience Requirements:

• Minimum of 4 years clinical/statistical programming experience within pharmaceutical clinical development/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with expertise in CDSIC/SDTM.

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Warsaw - PL: zł209,290 - zł253,607

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

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Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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R1599977 : Manager, SDTM Statistical Programming