Principal Statistical Programmer

Parexel International; Newton (MA); Remote; USD 100,000 - 140,000; Full time

Job summary

A leading global biopharmaceutical services company seeks a Principal Statistical Programmer to provide expertise in statistical programming for clinical trial projects. This full-time, remote role involves working closely with sponsors, ensuring quality and compliance with regulatory standards. The ideal candidate will have extensive experience in managing statistical programming tasks and leading project teams in a dynamic environment.

Benefits

Employee Referral Program

Qualifications

• 7 years of progressive experience in statistical programming.
• Internationally recognized qualifications in data handling and analysis are valuable.
• Strong background in clinical trial data is essential.

Responsibilities

• Provide technical support and expert advice on statistical programming projects.
• Monitor quality, timelines, and resource allocation for projects.
• Lead teams and liaise with various functional areas.

Skills

Statistical programming

Data analysis

Project management

SAS/BASE

FDA 21 CFR Part 11 regulations

ICH-GCP guidelines

CDISC standards

Education

Bachelor's degree in Statistics, Mathematics, Pharmaceutical Science, or related field

Tools

SAS/STAT

SAS/SQL

SAS/MACRO

Job description

Name of Employer: Parexel International LLC

Position Title: Principal Statistical Programmer

Position Location: 275 Grove Street, Newton, MA 02466

Hours: Full Time / 40 hours

Summary of Duties: Provide technical support and expert advice to internal and external sponsors on statistical programming projects to support clinical trial activities. Work independently to support various programming activities related to analysis and reporting of clinical study data. Fill the Statistical Programming Lead role on projects and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas. Monitor quality, timelines, resource allocation, and productivity in relation to budget. Project management for statistical programming. Advise and negotiate statistical programming timelines.

Education requirements: Bachelor’s degree in Statistics, Mathematics, Pharmaceutical Science, Data Analytics or related field of study. Employer will accept post-secondary academic coursework and/or relevant work experience which is evaluated as equivalent to a U.S. Bachelor’s degree in accordance with 8 CFR §214.2(h)(4)(iii)(D).

Experience requirements: 7 years of progressive experience in statistical programming.

Special Skills or Other Requirements: Applicants must have demonstrated experience with:

1) Programming and reporting process.

2) FDA 21 CFR Part 11 regulations;

3) ICH-GCP, CDISC, and WSOP guidelines;

4) Analyzing data from Phase I, II, and III clinical trials;

5) SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS Data Step, Proc Step, and Functions;

6) Generating reports, tables, and listings for statisticians;

7) Building structured, CDISC, SDTM or ADaM databases for clinical studies; and

8) Leading teams in a statistical programming environment.

*100% Remote reporting to Newton, MA.

*Position eligible for Employee Referral Program*

To apply: Individuals interested in applying for the position may email a resume with Job #LV0209 to [e-mail].

EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.