Overview

The primary responsibilities of this position will be to lead database or statistical programming activities and provide end to end programming support in planning, specifying, designing, developing, and implementing solutions for the clinical trials in accordance with applicable processes. Provide extensive technical expertise as part of the Database and Statistical Programming (DSP) team to develop, test, maintain, validate, and document programs to meet business needs. Provide support to the development of project-related solutions to the full scope of database and statistical programming tasks.

Responsibilities

• Leads all the programming activities, including planning, organizing, delegating, coordinating, and managing programming activities, from start to finish by overseeing all development, validation, and production of programs for a set of studies or multiple clients
• Provides technical solutions to a wider range of problems with higher level of complexity
• Independently determines and develops approach to solutions
• Adapts to changing circumstances, policies, work assignments, and/or team members
• Creates and maintains complete and up-to-date study documentations in compliance with Pharmapace and regulatory standards
• Tracks projects against goals and submits status reports to project management
• Recommends technical and process solutions that can be used or developed to increase efficiency of project work
• May maintain or develop departmental procedures and standards
• Contributes to the development of department-level standards, tools and templates
• Contributes to user aspects of technical infrastructure or business process initiatives with a focus on statistical programming, data process and analysis reporting procedures
• Negotiates effectively within project teams and working groups for reasonable timelines and scope, also negotiates alternative timelines based on resourcing / priority constraints
• Manages projects independently
• Mentors junior analysts/programmers
• May supervise junior analysts/programmers

Qualifications

Education

• Bachelor’s or above degree in statistics/biostatistics, computer sciences, or related fields

Experience

• Minimum 8 years of experience in the pharmaceutical/biotech industry for Bachelor’s and 6 years for Master’s
• Experience in leading the programming activities for submissions

Skills

• Excellent skills in SAS programming or clinical studies
• Excellent clinical trial knowledge is preferred
• Working knowledge of other software such as S-plus and WinNonlin is preferred
• Excellent knowledge in industry standards, such as the ICH guidelines, CDISC data standards, 21 CFR Part 11, and FDA guidelines, is required
• Excellent organizational skills, time management, and ability to coordinate workload and meet established timelines
• Excellent communication and interpersonal skills to effectively interface with other

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.