Job Description

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 (e.g. 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.

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