Manager, Statistical Programming
About The Position
Bristol Myers Squibb Company is hiring a(n) Manager, Statistical Programming. This role provides programming expertise to clinical project teams to support the development, regulatory approval, and market acceptance of company products. The position involves designing, developing, and implementing technical solutions to integrate, analyze, and report clinical data, as well as performing programming validation to ensure the quality of analysis datasets and programming outputs. The role also supports clinical project teams and vendors by developing programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, Standard Operating Procedures (SOPs), and work practices. Additionally, the role involves developing, validating, troubleshooting, and maintaining statistical programs and utilities, supporting electronic submissions preparation and review, and assessing key planning documents such as the statistical analysis plan, data presentation plan, and data review plan. Collaboration with vendors on project standards, programming conventions, programming specifications, and file transfers is also a key aspect of this position. This role allows for 100% telecommuting.
Requirements
- Master’s degree or foreign equivalent degree in Information Technology, Statistics, Biostatistics, Computer Science, or related field, and two (2) years of related work experience as a Biostatistician or related occupation.
- Two (2) years of experience with/in: Statistical programming within pharmaceutical clinical development
- Two (2) years of experience with/in: Reviewing statistical analysis plans, data presentation plans, or data review plans
- Two (2) years of experience with/in: Creating SAS programs to generate TFLs
- Two (2) years of experience with/in: Applying clinical data structures including Clinical Data Interchange Standards Consortium (CDISC) and relational databases
- Two (2) years of experience with/in: Using software tools and applications including XML to produce analysis datasets
- Two (2) years of experience with/in: Processing upstream statistical data including eDC and SDTM
- Two (2) years of experience with/in: Providing outputs to meet downstream requirements including ADaM, Data Definition Table, and e-submissions
- Two (2) years of experience with/in: Leveraging statistical terminology, clinical trial methodologies, protocol designs, and global regulatory standards
- Two (2) years of experience with/in: Working with Linux operating system.
Responsibilities
- Provide programming expertise to clinical project teams to support the development, regulatory approval, and market acceptance of company products.
- Design, develop, and implement technical solutions to integrate, analyze, and report clinical data.
- Perform programming validation to ensure quality of analysis datasets and programming outputs.
- Provide programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis.
- Support clinical project teams and vendors, including deployment of programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, Standard Operating Procedures (SOPs), and work practices.
- Develop, validate, troubleshoot, and maintain statistical programs and utilities in accordance with pre-defined specifications and standards.
- Support electronic submissions preparation, and review.
- Review planning documents to ensure alignment with project objectives, programming assumptions, requirements, and activities.
- Communicate issues and risks and contribute to its remediation.
- Assess key planning documents including statistical analysis plan, data presentation plan, and data review plan.
- Collaborate with vendors on project standards, programming conventions, programming specifications and file transfers.
Benefits
- Annual discretionary bonus
- Healthcare: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Work-life benefits
- Paid Time Off
- Flexible time off (unlimited, with manager approval)
- 11 paid national holidays
- 160 hours annual paid vacation for new hires with manager approval
- 3 optional holidays
- Unlimited paid sick time
- Up to 2 paid volunteer days per year
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- Annual Global Shutdown between Christmas and New Years Day.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
