Senior Principal Clinical SDTM Programmer

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Key Responsibilities:


Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications, datasets, define.xml, SDRG, Annotated CRF) for BMS studies

Serve as Study SDTM Programming lead for all regulatory submissions

Expertise in SDTM automation tools, macros and using them for SDTM programming

Strong understanding of Rave EDC, SDTM metadata and metadata driven solutions

Review the Study EDC specification and ensure all collected study data (including external) is mapped appropriately in target SDTM model

Design the SDTM specification as per the CDISC SDTM IG and BMS standards and ensure they meet downstream ADaM and Reporting requirements

Annotate CRFs and Review annotated CRFs in accordance with BMS guidelines and appropriate metadata to reflect tabulation datasets

Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and other Quality tools

Collaborate with stakeholders and Study team members to manage study timelines, and resolve issues

Represent SDTM Programming function in Study team meetings as well as cross-functional working groups and process improvement activities

Provide subject matter expertise in defining the mapping relationships between source EDC and target SDTM domains

Support and identify areas for automation & innovation as process enhancements to improve quality of work and efficiencies

Remain abreast with latest industry trends in standards implementation, review published papers and participate in industry conferences

Direct responsibility preparing and presenting SDTM information cross functionally

Resolve problems as they arise within defined procedures and escalate if necessary at appropriate time

Represent as internal team leader who decides best course of action

Negotiate, assess, and monitor project priorities/timelines for SDTM components

Review synopsis and/or protocol and provide comments for the Review Committee

Provide programming input to CRF and External Data from an SDTM perspective

Oversee development of SAS programs to generate SDTM datasets

Validation of SDTM datasets to ensure meets regulatory compliance

Provide input to the design of the clinical trial database from an SDTM perspective

Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros

Partner with CROs and act as a primary point of contact for SDTM programming activities

Provide SDTM programming input into the SOW activities and review associated budget

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


Other Activities


Build networks to achieve influence with other functions and represent as SDTM Programming technical expert.

Lead/participate in department and/or cross-functional process improvement initiatives as well as special projects and create efficiencies within programming processes

Author, review, approve and train on department procedures including SOPs, Working Practices and Guidance Documents

Ensure consistency and adherence to standards and governance within their therapeutic area and the department

Routinely interface with cross-functional team members during the study startup and execution.

Lead/Participate in programming team meetings when appropriate

Represent programming during internal audits as well as Health Authority audits

Align with the department and company strategy and model


Skills/Knowledge Required:


BA/BS degree or equivalent in a relevant scientific discipline with a minimum of 5 plus years of experience supporting clinical trials for regulatory submissions

Experience as a Lead Programmer overseeing the SDTM activities of support programmers as well as CRO/external vendors

Strong project management skills; good communication skills; ability to work in a cross-functional team environment

Expertise with CDISC standards, specifically CDASH and SDTM

Solid understanding of ADaM standards

Hands on experience using Pinnacle21 to generate and validate SDTM deliverables

Thorough understanding of clinical data structures, relational database structures, and data exchange with alternative data formats

Knowledge of clinical study design. Detailed knowledge and experience in CRF design, central laboratories, programming databases, query resolution, data validation

Demonstrates expertise in the handling and processing of upstream data including multiple data sources, data workflows, eDC, external data

Demonstrates expertise in providing outputs to meet downstream requirements including ADaM, Data Definition Table, e-submission

Proficient in programming languages and demonstrated proficiency in using SAS to produce SDTM datasets

In-depth knowledge of FDA/ICH guidelines, industry/technology standard practices and good programming practices

In depth understanding of regulatory, industry, and technology standards and requirements

In depth understanding of statistical terminology, clinical tests, medical terminology, and protocol designs

Demonstrated ability to work in a team environment with clinical team members

Excellent communication ability, as well as written, verbal, interpersonal and organizational skills


Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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