Principal Statistical Programmer

MedStar Health; Newton (MA); Remote; USD 100,000 - 130,000; Full time

Job summary

A leading health organization is seeking a Principal Statistical Programmer to provide expert statistical programming support for clinical trial activities. This full-time position involves project management, technical guidance, and collaboration with various stakeholders, ensuring high-quality data analyses and reporting. Qualified candidates will have a Bachelor's degree and significant experience in statistical programming, particularly in a clinical research environment.

Benefits

Employee Referral Program

Qualifications

• Requires a Bachelor's degree and 7 years of statistical programming experience.
• Demonstrated experience with statistical programming processes and regulatory guidelines.

Responsibilities

• Provide technical support and expert advice on statistical programming projects.
• Monitor project quality, timelines, and productivity.
• Lead statistical programming initiatives and liaise with various stakeholders.

Skills

Programming and reporting process

FDA 21 CFR Part 11 regulations

ICH-GCP, CDISC, guidelines

Analyzing data from Phase I, II, and III clinical trials

SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO

Generating reports, tables, and listings

Building structured, CDISC databases

Leading teams in a statistical programming environment

Education

Bachelor's degree in Statistics, Mathematics, Pharmaceutical Science, Data Analytics

Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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.