Job Description

BioPier is looking for multiple Biostatistical Analysts from recent Ph.D., MSc/MPH, and BSc graduates to join our growing consulting team. The candidates will analyze data for Phase I-IV clinical trial studies for biopharmaceutical companies.

RESPONSIBILITIES:

Under minor supervision, the candidate will be conducting biostatistical analysis using SAS software for clinical trial studies:

Drug Efficacy/Safety Analysis Tasks

• Follow statistical analysis plans(SAP), develop AdaM dataset specifications, and write SAS programs to produce ADaM datasets;
• Produce or validate summary tables, data listings, and graphs (TLGs) using SAS software;
• Build programming specifications for the ADaM database based on the statistical analysis plan and report specifications.

Industry Data Standardization - CDISC SDTM Tasks

• Follow the CDISC SDTM Implementation Guide, write SDTM mapping specifications and SAS programs to produce or validate CDISC-compliant SDTM datasets;
• Review and annotate eCRFs (Case Report Form).

Regulatory Submission (eCRT/eCTD) Tasks

• Produce/validate eSubmission (define.xml) packages for FDA and PMDA New Drug Approval, write eSubmission Reviewer's Guide.

Other Tasks

• Develop programming procedures, system macros for process improvements;
• Write or review standard operation procedures for biostatistics or SAS programming activities.

QUALIFICATIONS:

• Minimum Bachelor's degree in (bio)statistics, computer science, biomedical science, or related field; A Master's degree, a Ph.D. degree is preferred;
• SAS Advanced Programming Certification is strongly preferred;
• Excellent and proven SAS programming and statistical analysis skills using SAS BASE, STAT, GRAPH, and MACRO. SAS Certified Base and/or Advanced Programmer preferred;
• Other programming experiences will be considered as well.

WE LIKE TO LEARN YOUR OVERALL PROGRAMMING SKILLS. IF YOU WORKED IN SAS LANGUAGE BEFORE, PLEASE SUBMIT YOUR SAS CODE TO DEMONSTRATE YOUR SAS SKILLS. IF YOU WORKED IN OTHER LANGUAGES, YOU CAN SEND US SOME OF YOUR CODING SAMPLES AS WELL. (PLEASE REMOVE CONFIDENTIAL INFORMATION.). IF YOU LIKE TO SEND IT THROUGH EMAIL LATER, PLEASE SEND IT WITH A COVER LETTER TO HR @ BIOPIER.COM

COMPENSATION:

We offer very competitive compensation based on your experiences. We offer paid holidays, 3-week vacations, medical/dental insurance, 401k, bonus, on-site gym, and many other benefits. We have a friendly team and a flexible working environment. We sponsor H1B visas and Green cards.

Due to COVID-19, all open positions are currently remote. When our office resumes operation, we may ask you to work from our office in Burlington, MA.

Company Description

We are a team of experienced consultants in biostatistics and programming. We serve high-profile pharmaceutical companies to evaluate drug efficacy and safety for their essential clinical trials. We operate 100% in the US and have a stable business and workforce. We are honored to be selected by Fortune 500 pharmaceutical companies as their preferred provider. Our team has successfully serviced 100+ clinical studies/projects in the past five years.