Auftragsdetails

Detailed 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 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 these as assigned. Accessing and converting data to SAS datasets and other file types from 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.

• Mentoring less-experienced statistical programmers.

• Overseeing and reviewing the day-to-day work of statistical programmers as needed.

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: 7 years’ experience in SAS/statistical programming, preferably for clinical trials in a pharmaceutical/CRO environment, or Master’s degree in an applicable discipline with 5 years’ experience.

• 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.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.