Operating Systems Programming Manager jobs in Somerset, NJ

We are an EasyHiring recruiting company that is looking for candidates for our partners for the position of Manager, Statistical Programming in East Rocky Hill, NJ for work in Brisbane, CA.

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.

Key Responsibilities:

• 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.

Job Type: Full-time

Ability to Relocate:

• Plainsboro Center, NJ: Relocate before starting work (Required)

Work Location: On the road