Sr. Manager, Biostatistical Programming

1 month ago

San Diego, United States Bristol Myers Squibb Full time

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.

RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC) and breast cancer. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

The Senior Manager of Biostatistical Programming at RayzeBio will be accountable for development of clinical study related deliverables and timelines, oversee study vendors' programming deliverables, and support company internal requests.

Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

* Oversee vendors' activities, and review vendors' deliverables to ensure quality.
* Participate in reviewing, analyzing, and reporting clinical trial data and generating outputs to support DSUR/IBs, publications, FDA meeting briefing documents, and other internal ad-hoc requests.
* Collaborate with cross-functional teams to review critical study documents and perform data reviews for ongoing studies.
* Oversee CDISC data package development for clinical studies to support CSRs and future regulatory submissions.
* Create SAS macros/applications to streamline processes and enhance efficiency.
* Create/QC SDTM/ADaM data specifications, create/QC CDISC datasets and provide/QC outputs based on protocols/SAP.

Skills and Knowledge:

* Proven ability to manage CRO relationships and oversee programmed deliverables.
* Advanced skills in SAS programming and statistical reporting.
* Knowledge with FDA and ICH regulations and guidelines, and clinical trial methodologies.
* Good written and verbal communication skills. Be able to work productively in a fast-paced collaborative environment.
* Willing to travel approximately 10% of the time. Evening and weekend work will be involved.

Qualifications:

* A bachelor's degree required in statistics, mathematics or equivalent
* At least 10 years' experience in the pharmaceutical industry
* Oncology therapeutic area experience

Preferred Qualifications:

* Master's degree in statistics or computer science with at least 7 years' of programming experience

#LI-Remote

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.

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