Director, Biostatistical Programming

Field - United States

Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines to patients with serious diseases.

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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, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

The Director 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. The successful candidate will report to the Head of Biostatistical Programming.

Key Responsibilities:

  • 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

  • Support head of Biostatistical Programming in Establish programming and QC processes, and create related SOPs

  • Support head of Biostatistical Programming in Develop and maintain SAS programming infrastructure and process to ensure the quality and compliance in statistical programming deliverables

  • Create SAS macros/applications to streamline processes and enhance efficiency

Education & Experience:

  • A bachelor's degree required in statistics, mathematics or equivalent with at least 15 years’ experience in pharmaceutical industry; or a master's degree in statistics or computer science with at least 12 years’ programming experience is preferred.

  • Oncology therapeutic area experience required.

  • Proven ability to manage CRO relationships and oversee programmed deliverables.

  • Advanced skills in SAS programming and statistical reporting.

  • In-depth knowledge of CDISC standards for SDTM, ADaM and FDA electronic data submission requirements.

  • Advanced 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.

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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

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Tags: CDISC Computer Science Excel Mathematics Pharma Privacy SAS Statistics

Perks/benefits: Career development

Region: North America
Country: United States

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