Clinical SAS Programmer

Position Summary: 

Reporting to the Senior Director of Biostatistics, this position is responsible for generating safety displays and independently programming quality control (QC) output for acceptance of deliveries developed internally and from 3rd party vendors.  Additionally, the position will build efficiencies in the Biostats department to streamline the programming efforts related to safety review deliveries and QC checks.

Essential Duties and Responsibilities:

• Independent SAS programming QC of summary tables (efficacy, safety, demographics, disposition and exposure) for internally produced displays and displays provided by 3rd party vendors.
• Generating high quality subject listings and graphs to support safety review.

• Utilization of professional expertise in writing and validating programs (primarily SAS) for analysis datasets, tables, figures and listings for clinical studies and/or for regulatory submissions

• manage and coordinate the programming activities to ensure department, program and goals and objectives are consistently met to the highest standard of quality and timely

Additional Responsibilities:

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Required Education and Experience:

• Bachelor’s degree in a technical field plus at least 5 years of SAS programming in a clinical environment (pharmaceutical, biotech, or clinical research organization) or equivalent work experience.

Preferred Education and Experience:

• Familiarity with regulatory guidelines for statistics and programming (ICH E9).
• Experience building multiple projects in R Markdown.
• Experience developing projects in R Shiny.

Required Knowledge, Skills, Abilities & Behaviors: 

• Good communication skills both written and oral.
• Their work will require hands-on technical programming skills in SAS.
• The position will require a good understanding of the structure of standard safety displays (e.g. AE, Labs, Vitals and ECG tables, listings and figures).
• The position should also be familiar with ADaM and SDTM dataset structure and understand error messages from standard pinnacle 21 reports

Work Conditions:

• This position will be fully remote.
• This role routinely uses standard office equipment such as computers, phones and photocopiers.
• This position is required to work occasional nights and weekends to meet company demands.

Physical Demands:

While performing the duties of this job, the employee is occasionally required to stand, walk, use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms.  The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl; talk or hear. 

The employee must occasionally lift and/or move objects up to 10 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus. 

The safety and well-being of our employees during the pandemic has been and continues to be a top priority. Toward that end, and based on the latest recommendations of scientists and health officials that the COVID-19 vaccine provides the best protection against severe infection, we are requiring that all successful applicants for open positions at all of our office locations must be fully vaccinated against COVID-19 as a condition of employment. Accommodations may be made in accordance with applicable law.

All your information will be kept confidential according to EEO guidelines.