Company: BioPier, LLC. (a Veramed Company)
Location: Burlington, MA
Position: Senior/Principal Programmer
Type: Full-time
Brief Description: BioPier, LLC., a Veramed company, is seeking highly motivated, inquisitive, coachable and skilled programmers. We prefer a master's degree or higher in STEM disciplines, who have strong programming, analytical, and data science skills and are looking to launch their careers in the fast-growing field of drug development and clinical data science. This position offers a unique opportunity to work alongside the talented BioPier team, receive hands-on training, and contribute to high-impact projects in the clinical and biostatistics domain. This is a paid, Full time benefit eligible position.
This would be an exciting opportunity for a Senior or Principal level Statistical Programmer to join us on a permanent basis in the United States. We can offer home and/or office working, training and support as well as a competitive package
Position Responsibilities:
Statistical Programming:
Conduct Phase I-IV Clinical Study Reports (CSRs) to evaluate study safety and efficacy
Work on data science and standardization projects, including CDASH, CDISC SDTM, and ADaM
Compile Integrated Summaries of Safety and Efficacy for drug approval
Prepare regulatory patient safety reports (PBRER, DSUR, PSUR, SWG, SRT, EU-RMP, DMC, IB)
Support Independent Data Monitoring Committees and create patient profiles and narratives
Veramed prides itself on two key areas: providing the highest quality statistics and programming consultancy for its clients, and giving its employees an industry leading working environment with support and training for career growth.
The purpose of the role is to provide programming support to the statistics and programming
department across a range of projects, clients and therapeutic areas. The Senior or Principal Programmer may also perform a supervisory role (eg line management and/or project management).
Key Responsibilities
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based
on current business needs.
Technical
Perform review of clinical trial documents including protocols, SAPs, CRFs, CSRs
Author, review and approve study TFL shells and dataset specifications
Author, validate and document SAS programs for datasets, TFLs and macros, applying good
programming practice
Identify data issues and outliers
Complete, review and approve CDISC Validation tool reports
Identify data and standards issues and resolve or escalate as appropriate
Awareness of emerging standards and associated impact to ongoing and future planned trials
Maintain proficiency in SAS and awareness of developments
Maintain study master file documents and any other documents that are required to be audit ready
General
Lead internal and client study, project and cross functional team meetings effectively
Present study updates internally and at client meetings
Share scientific, technical and practical knowledge within the team and with colleagues
Perform work in full compliance with applicable internal and client policies, procedures, processes
and training
Build effective collaborative working relationships with internal and client team members
Ensure learnings are shared across projects or studies
Develop and provide internal technical training where appropriate
Lead process improvement initiatives
Minimum Qualification Requirements
BSc, MSc or PhD in numerical discipline (or relevant equivalent industry experience)
At least 4 years of relevant industry experience
Other Information/Additional Requirements
Understanding of clinical drug development process, relevant disease areas, endpoints and study
designs
WHAT TO EXPECT:
- A warm, friendly working environment in which to thrive both personally and professionally.
- A supportive, open-door management policy that will aid in your development and provide you with the tools to take your career to the next level.
- A truly unique CRO that's doing something different when it comes to managing staff, projects and building relationships in the industry.
- The ability to own your role and develop your skills and experience.