Senior Scientist, Statistical Programming, Late-Stage Oncology (Hybrid)

MSD; Rahway (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

MSD's BARDS department seeks a Statistical Programmer to support late-stage drug and vaccine clinical development. The role includes leading programming activities and delivering analysis datasets, tables, listings and figures for regulatory submissions and post-marketing support.

The incumbent designs and maintains statistical datasets, collaborates with clinical development, outcomes research and safety teams, and serves as the programming point of contact throughout the product lifecycle.

Qualifications

• Experience with statistical programming for late-stage drug development.
• Ability to lead projects and coordinate cross-functional teams.
• Familiarity with SOPs and good programming practices.

Responsibilities

• Effective analysis and report programming development and validation utilizing global and TA standards and SOPs.
• Maintain and manage a project plan including resource forecasting.
• Coordinate the activities of a global programming team that includes outsource provider staff.
• Membership on departmental strategic initiative teams.

Skills

Statistical programming

Project coordination

Education

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences

Job description

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our Company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

This position supports statistical programming activities for late-stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.

The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.

The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.

For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.

Primary Activities:

• Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices

• Maintain and manage a project plan including resource forecasting

• Coordinate the activities of a global programming team that includes outsource provider staff

• Membership on departmental strategic initiative teams

Skills

Education and Minimum Requirement:

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences,