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Manager, Statistical Programming, SDTM Implementation

Employer
Bristol Myers Squibb Company
Location
Lawrence Township, New Jersey
Start date
Apr 1, 2024

View more

Discipline
Information Technology, Bioinformatics
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us .

This position 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 .
  • 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 expertise/support
Degree Requirements"
  • BA/BS in a relevant scientific discipline such as Life Sciences, Pharmaceutical sciences, Statistics, or Computer science.
Experience Requirements"
  • Minimum of 4 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with expertise in CDSIC/SDTM with an end to end understanding of clinical drug development lifecycle. Please see job description for detailed expected experience.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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 an inclusive culture, promoting diversity 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

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

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.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
US

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