Who Are We?

Founded in 1997 and built upon 20+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego's Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients.

Who Are You?

You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important to the team so you take pride in delivering great work. You believe anything worth doing is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently.

‍

What is the Primary Objective of the CDISC SAS Programmer?

You will play a lead role in supporting the statistical analysis and reporting of data from clinical and nonclinical studies and have extensive knowledge of CDISC SDTM and ADaM data structures.

‍

To Succeed in this Position:

• You should have Bachelor's degree in Statistics, Mathematics, or Computer Science or in a related field.
• You should have a minimum of 4 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
• You have a knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.
• You should be able to demonstrate extensive knowledge of SDISC SDTM and ADaM data structures and controlled terminology, and FDA guidances and technical conformance guides covering the electronic submission standardized study data.
• You have excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
• You have great verbal/written communication and interpersonal skills to effectively interface with others.
• You have the ability to think strategically in order to improve current processes.
• You have the ability to work independently and prioritize with minimal daily instruction.
• If you have NDA submission experience that is a plus.

***San Diego-based not required but highly preferred.

‍

Your Main Responsibilities and Duties Include:

• Generating analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials in support of regulatory submissions and publications.
• Performing quality control for SAS programs and other study documents (e.g., presentations and reports).
• Generating SDTM datasets, ADaM datasets, and Define.xml or Define.pdf files.
• Maintaining complete and auditable documentation of all programming activities.
• Reviewing output across SAS programs to ensure consistency.
• Providing statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
• Supporting our Clinical Data Managers with data review via SAS programmed data checks and listings.
• Assisting in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
• Participating in the development and/or maintenance of departmental procedures and standards.
• Reviewing CRFs, edit check specifications, and table mock-ups.
• Working collaboratively with cross functional groups, study team, and vendors.
• May assist in creation of table, figure, or listing mockups under supervision of statisticians.

‍