RayzeBio Associate Director – Biostatistical Programming
Job Description
Description
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. 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 .
The Associate 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.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
- Oversee vendors’ activities, and review vendors’ deliverables to ensure quality
- Create/QC SDTM/ADaM data specifications, create/QC CDISC datasets and provide/QC outputs based on protocols/SAP
- 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
Education and Experience
- A bachelor’s degree required in statistics, mathematics or equivalent with at least 10 years’ experience in pharmaceutical industry; or a master’s degree in statistics or computer science with at least 7 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.
Physical demands
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.
Work Environment
The noise level in the work environment is usually moderate.
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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.
Compensation Overview:
San Diego – RayzeBio – CA: $190,539 – $230,888
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into
Company
Bristol Myers Squibb
Location
, , Canada
Country
Canada
Salary
100.000
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