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Senior Statistical Programmer
4 weeks ago
About the Role:
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, BTA provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.
About the Job:
As a Senior Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex projects for a renowned, innovative and global top pharmaceutical company. You will be involved in liaising with the entire study team as needed, including Clinical, Medical Writing, Safety and Biometrics.
Main Responsibilities:
* Plan, execute and oversee all programming activities on a study, including but not limited to: resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments, etc.
* Oversee SDTM, ADaM and TLF development, perform Senior Review of outputs
* Liaise with other Sponsor departments for additional programming needs, as required to support publications, medical writing and additional development needs and analyses
* Support/oversee submission activities (especially in late phase team)
* Ensure all activities are conducted efficiently, with appropriate set-up of needed tools and macros, prioritizing quality at all times
* Mentor less-experienced team members in best practices around SDTMs, ADaMs and TFLs while ensuring adherence to department standards and processes
Requirements:
* Ideally, a degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
* In lieu of the above: professional experience in statistical programming within clinical trials in a biotech, CRO or pharmaceutical company
* Solid experience with complex clinical trials (minimum 5 years) and the corresponding datasets' content (safety and efficacy) and endpoints
* Ideally you will have knowledge in all aspects of clinical trials, from initial study set-up to study completion, with an understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management
* Expert knowledge of base SAS, SAS macros, SAS/STAT and in debugging SAS programs
* Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guides and submission standards
* An autonomous, collaborative work style, a curious mind and a keen attention to detail
* Fluency in English - both verbal and written - is a must
About BTA:
BTA is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.
