Clinical Statistical Programmer
1180 Veterans Boulevard South San Francisco, CA 94080
Bayside Solutions is seeking a highly experienced Clinical SAS Programmer to be part of our Client’ s team in South San Francisco. This is an opportunity to work with a local Pharmaceutical company focusing on the discovery and development of novel drugs for treatment in multiple indications.
The ideal Clinical SAS Programmer for their team must have strong communication skills, be a team player, display strong leadership skills and be able to be work independently with minimal direction. In order to be successful in this role, someone must have 10 years of experience working in Statistical Programming within the pharmaceutical industry and strong knowledge of SDTM/AdAM validation specifications.
A career with our Client can provide you with an encouraging and fulfilling work environment, with recognition for accomplishments and the opportunity to advance your career while sharing in the excitement of the organizations growth and success!
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
- An opportunity to join a company focused on the development and delivery of novel, targeted drugs for treating a variety of therapeutic areas.
- Work for a company that is local to the bay area, in the beautiful South San Francisco area.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Validate that SDTM/AdAM specifications and data files for key studies meeting the submission requirements as outlined in cDISC guidelines.
- Ensure the edit check specification and data quality for on-going clinical study.
- Manage database transfer processes and database specifications in collaboration with outside vendors.
- Create derived data specifications based on statistical analysis plans.
- Create SAS programs for clinical trial data summaries and analysis.
- Produce derived data sets for safety and efficacy, and summarize clinical trial data (tables, listings and graphics).
- Supports achievement of major reporting deliverables and milestones.
- Ensures documentation and archival of statistical programming deliverables including analysis databases, summaries, programs and specifications.
- Bachelor degree in biostatistics, computer science, or comparable with demonstrated technical ability, with a minimum of 7 years’ experience as a Statistical Programmer in the pharmaceutical industry.
- Proficient of SAS programming in a regulated clinical research environment.
- Must have previous experience filing eCTD drug registration with FDA.
- Represents function in external professional initiatives and organizations to identify industry best practice.
- Ability to interact with Statisticians, Clinical Data Managers, Clinical Trial Project Managers, and other personnel to provide programming support for clinical studies and ad hoc analyses.
- Must be able to work in-house, in South San Francisco office, Monday-Friday, 40 hours per week.
- The ideal candidate must be able to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
- Experience in NDA/sNDA submissions is highly desired but not required.
- Strong leadership skills and team work spirit.