Auftragsdetails

Detailed Description

Essential Functions:

• Serving as a lead SAS/Statistical Programmer on ProPharma programming projects.
• Programming of datasets (CDISC and non-CDISC) and outputs
• QC of datasets (CDISC and non-CDISC)
• Ensuring the quality and timeliness of programming deliverables.
• Providing leadership to programming teams and projects to achieve organizational and client objectives.
• Ensuring appropriate staffing, training, and adherence to SOPs including effective validation practices for Treximo programming teams.
• Responsible for financial management of assigned projects/programs, including revenue recognition, changes in scope, and participation in internal project review meetings, including liaising with finance group as needed.
• Providing management of direct reports: giving assignments, reviewing progress, writing, delivering performance reviews, and providing leadership.
• Maintaining knowledge of regulatory guidelines and industry standards as applicable to clinical studies with specific emphasis on programming activities.
• Participating in the development and maintenance of the ProPharma SAS programming environment within regulatory requirements.
• Reviewing, updating, improving, and creating new standard program templates and macros to be used by programmers across the department to increase efficiency and consistency.
• Writing, reviewing, and updating SOPs and Work Instructions.  Overseeing updates to SOPs and Work Instructions when written/updated by senior/principal-level programmers.
• Assisting in developing and/or implementing strategies and policies for programming services aligned with maximizing quality and reliability of deliverables at an optimized cost.
• Other duties as assigned.

Necessary Skills and Abilities:

• Strong project management skills and technical aptitude.
• Excellent skills in SAS programming.
• Strong communication skills.
• Ability to write and present information effectively.
• Self-Motivated.
• Knowledge of CDISC standards (e.g., SDTM, ADaM, Define.xml) preferred.
• Knowledge of the FDA Common Technical Document for Data Standards preferred.
• Strong understanding of the ICH and GCP regulatory requirements.
• Understanding of FDA and PMDA guidelines preferred.

Educational Requirements:

• Minimum: Bachelor’s degree in statistics, computer science, mathematics, or a related science discipline, or a combination of other education with applicable professional experience.

Experience Requirements:

• Minimum 9 years’ experience in SAS/statistical programming, preferably for clinical trials in a CRO/pharmaceutical environment.
• Experience managing multiple programming-related resources at one time across multiple projects.