Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Job Description

Essential Functions Include:

• Providing statistical programming and validation for clinical study reports, final/interim analyses, meetings, other types of analyses, and reports throughout the project.
• Serves as a lead SAS/Statistical Programmer on ProPharma Group programming projects.
• Coordinating programming activities among the study programmers to achieve timely deliveries in the following areas: SDTM datasets, ADaM or analysis datasets, statistical tables, listings, and figures (TLFs), data reconciliation reports, and other internal and external reports.
• Reviewing, updating, improving, and creating new standard program templates and macros to be used by programmers across the department to increase efficiency and consistency.
• Reviewing and providing suggestions to department management for updates to SOPs and Work Instructions, and writing/updating specified documents as assigned.
• Accessing and converting data to SAS datasets and other file types from the database management system and PC file formats (e.g., Microsoft Excel, text files).
• Working with external vendors to develop and/or monitor the content and structure of SAS datasets and other files.
• Overseeing programming activities by external vendors (e.g., CROs).
• Working closely with statisticians and other statistical programmers to generate and validate TLF outputs; review data specifications to ensure accuracy and ensure the quality and soundness of statistical programming algorithm.
• · Providing input in developing specifications of tabulation and analysis datasets, validation plans, and other related documents.
• Reviewing data submission packages including define files and data reviewers guide documents.
• Working independently to accomplish tasks and goals defined by supervisor as well as suggesting new ideas to improve the programming process.
• Mentoring less-experienced statistical programmers.

Qualifications

Qualified candidates must have:

• Minimum: Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related discipline, or a combination of other education with applicable professional experience.
•  Minimum 5 years’ experience in SAS/statistical programming, preferably for clinical trials in a pharmaceutical/CRO environment.
• Project leadership experience in a pharmaceutical/CRO programming environment preferred.
• Experience using Base SAS, SAS/Macro, SAS/ACCESS, SAS/STAT, Microsoft Word, and Microsoft Excel. Experience with SAS ODS Graphics preferred.
• Experience following CDISC data standards (e.g., SDTM, ADaM) preferred.
• Understanding of FDA, PMDA, and ICH guidelines preferred.
• Good organization, time management, and attention to detail needed to work in a fast-paced environment under tight deadlines while maintaining focus on details and quality.
• Applies good judgment and demonstrates initiative to resolve issues.
• Strong written and interpersonal communication skills needed to work effectively in a team environment.

Additional Information

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***