Bristol Myers Squibb Manager, SDTM, Statistical Programming in San Diego, California
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
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 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.
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
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
BA/BS degree or equivalent in a relevant scientific discipline with a minimum of 4 plus years of experience supporting clinical trials for regulatory submissions CDISC
Strong project management skills; good communication skills; ability to work in a cross-functional team environment
Experience with CDSIC standards including CDASH or SDTM/ADaM
Hands on experience using Pinnacle21 to generate and validate SDTM deliverables
Knowledge of clinical study design. Detailed knowledge and experience in CRF design, central laboratories, programming databases, query resolution, data validation
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
Demonstrate ability to work in a team environment with clinical team members
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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Company: Bristol Myers Squibb
Req Number: R1540932
Updated: 2021-10-28 03:48:15.616 UTC
Location: San Diego,California
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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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