Manager, Statistical Programming

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Offer programming expertise to clinical project teams to assist in the development, regulatory approval, and market acceptance of company products.

• Design, develop, and implement technical solutions to integrate, analyze, and report clinical data.

• Conduct programming validation to ensure the quality of analysis datasets and programming outputs.

• Provide programming support for project teams, which includes the development of programming strategies, standards, specifications, and programmed analyses.

• Assist clinical project teams and vendors by implementing programming strategies, standards, specifications, and programmed analyses to adhere to regulatory requirements, Standard Operating Procedures (SOPs), and work practices.

• Develop, validate, troubleshoot, and maintain statistical programs and utilities in accordance with established specifications and standards.

• Support the preparation and review of electronic submissions.

• Examine planning documents to ensure they align with project objectives, programming assumptions, requirements, and activities.

• Communicate issues and risks, contributing to their resolution.

• Evaluate key planning documents, including statistical analysis plans, data presentation plans, and data review plans.

• Collaborate with vendors on project standards, programming conventions, programming specifications, and file transfers.

⛳️ Requirements

• The employer will accept a Master’s degree or a foreign equivalent in Information Technology, Statistics, Biostatistics, Computer Science, or a related field, along with two (2) years of relevant work experience as a Biostatistician or in a related occupation.

• Must possess two (2) years of experience in:

• Statistical programming within pharmaceutical clinical development;

• Reviewing statistical analysis plans, data presentation plans, or data review plans;

• Creating SAS programs to generate TFLs;

• Applying clinical data structures such as Clinical Data Interchange Standards Consortium (CDISC) and relational databases;

• Utilizing software tools and applications, including XML, to produce analysis datasets;

• Processing upstream statistical data, including eDC and SDTM;

• Providing outputs to meet downstream requirements including ADaM, Data Definition Table, and e-submissions;

• Leveraging statistical terminology, clinical trial methodologies, protocol designs, and global regulatory standards; and

• Working with the Linux operating system.

🏝️ Benefits

• Health Coverage: 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.

• Paid Time Off for US Exempt Employees: flexible time off (unlimited, with manager approval), and 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio employees).

• For Phoenix, AZ, Puerto Rico, and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours of annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.

• Eligibility for specific benefits listed on our careers site may vary based on the job and location.