- Creating SAS programs to generate analysis datasets and content for tables, listings, and figures.
- Performing programming validation to ensure the quality of analysis datasets and programming outputs.
- Providing programming support for project teams, including the development of programming strategies, standards, specifications, and programmed analysis.
- Supporting electronic submission preparation and review.
- Reviewing key planning documents such as statistical analysis plans, data presentation plans, and data review plans to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements, and assessing the impact on programming activities.
- Interacting with vendors regarding project standards, programming conventions, programming specifications, and file transfers.
- Providing leadership to ensure the quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance, and corporate and departmental SOPs and work practices.
- Identifying opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors.
- Providing support for improvement initiatives. Minimum Requirements:
To be considered for this position, the following qualifications are required: - A Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences.
- At least 5 years of programming experience in the industry is recommended.
- For positions in the US, military experience will be taken into account as industry experience.
- Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs.
- In-depth understanding of clinical data structure, including CDISC standards, and relational databases.
- Demonstrated skills in using software tools and applications such as MS Office, XML, and Pinnacle 21.
- Demonstrated ability in the handling and processing of upstream data, including multiple data forms, workflow, eDC, and SDTM.
- Demonstrated ability in providing outputs to meet downstream requirements such as ADaM, Data Definition Table, and e-submission.
- Good understanding of regulatory, industry, and technology standards and requirements.
- Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
- Demonstrated ability to work in a team environment with clinical team members. Preferred Requirements:
- A minimum of 5 years of clinical/statistical programming experience within pharmaceutical clinical development, supporting regulatory filings (e.g. NDA, BLA, MAA).
- Knowledge of the drug development process, clinical trial methodology, statistics, and familiarity with global regulatory requirements.
- Experience in using other software packages (e.g. R).
- Experience with the Linux operating system. If you find a role that interests you but doesn't completely match your resume, we encourage you to apply anyway. You could be just one step away from work that will transform your career and life.
The starting compensation for this job is a range from 102, ,000.00, plus incentive cash and stock
opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS
Career Site.
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 scienceTM , 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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 . Visit 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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Description
Working with UsChallenging. 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: .
Position Summary
Managers of Statistical programming provide comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of Bristol Myers Squibb (BMS) products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Managers of Statistical Programming develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams.
Key Responsibilities:
