Home   -   Contact Us  

Job Category:Clinical Development

Who We Are

Dart NeuroScience LLC (DNS) is a privately held company with offices in San Diego, CA.
 
DNS is a company discovering new technologies and developing new therapies to help maintain cognitive vitality throughout life. DNS's mission is to become the leading specialized pharmaceutical company for memory disorders by focusing on the discovery and development of innovative drugs with new mechanisms of action. These discoveries are firmly based in a careful examination of the genes involved in the reorganization of synaptic connections in the brain, a cellular/molecular process which underlies both implicit (motor skills) and explicit (facts and events) forms of memory.
Our unique company culture engages employees by promoting thought-provoking investigation and targeted research opportunities. Our collegial environment also recognizes the value of stimulating cross-functional communication and collaboration as catalysts in generating the creative spark that inspires novel approaches and produces ground-breaking results. We want to attract, retain, and reward the top talent in our field. If you are looking for a productive, meaningful career path in the area of neuroscience, we would like to hear from you!


Job Summary:

The Contract Statistical Programmer provides hands-on statistical programming support for statistics and clinical data management for clinical trials in support of Phase 1-2 clinical development and regulatory submission programs.

• Work closely with colleagues (other Biostatisticians, Data Management, Statistical Programmers, and Clinical Operations) and be part of study teams as needed
• Independently program SAS for clinical trials, exploratory analysis and cognition endpoints
• Independently validate primary endpoints using SAS
• Serve as project statistical programmer for some phase 1 or 2 studies
• Acts as the primary contact with the CRO for statistical programming related activities on studies that have been outsourced, as necessary along with the project lead/indication biostatistician
• Create and/or review programming for analysis datasets, tables, listings, and figures as well as SDTM/ADAM specifications and CDISC/SDTM
• May participate in User Acceptance Testing (UAT)
• Review detailed Statistical Analysis Plan (SAP) for programing requirements and be able to independently program validation of CRO outputs, and conduct independent data analysis per biostatistician guidance
• Ad-Hoc programming of clinical listings in support of data management and clinical operations as needed

Qualifications/Requirements:

• BS or MS in biostatistics or related degree (Computer Science) and at least 5-7 years of relevant industry experience in clinical statistical programming
• Familiar with FDA and ICH guidance and regulations as they relate to statistical programming, 21CFR Part 11, E9, good programming practices and software validation methods
• Ability to contribute to and review SOPs and work practices for statistical programming and oversee CRO programming for assigned projects
• Experience with working with CRO’s and overseeing compliance with standards, output and adherence to SAP and TFLs
• Ability to develop and support TFL, programming standards, and templates
• Familiarity and experience with CDISC STDM and ADAM
• Understanding and application of SAS MACRO programming
• Experience working with clinical data managers and CRO statistical programmers/statisticians
• Experience with graphical programming in SAS; ODS and PROC REPORT
• Ability to monitor adherence to programming timelines for assigned studies
• Understanding of basic statistical methods


Preferred Experience:
• Experience with SAS STAT procedures
• Ability to do exploratory analyses based on guidance from the project/study biostatistician
• Prefer familiarity with PK/PD clinical data, genotype and outcomes (PRO) data as well as clinical data as it relates to clinical trials
• Experience giving input to data managers on eCRF design/database capture and experience QCing tables as necessary
• Strong team work and communication skills
• Prefer experience with CNS clinical trials

 

Benefits:

DNS offers competitive salaries and a great benefits package including paid holidays, incentive bonuses, healthcare, vision, dental, long-term disability, life insurance, flexible spending, and a 401(k) retirement savings plan. Click here to learn more.


Dart NeuroScience is an Equal Opportunity Employer/Minorities/Women/Disability/Veterans.

EEO is the Law | EEO Policy