Principal Statistical Programmer, Early Phase

IQVIA; Durham (NC); Remote; USD 106,000 - 218,000; Full time

Job summary

A leading global provider of clinical research services is seeking a Principal Statistical Programmer to work remotely in the US or Canada. This role involves statistical programming for early phase studies, requiring strong SAS skills and knowledge of regulatory requirements. The ideal candidate will have extensive experience with Phase I studies and dataset creation.

Qualifications

• 10+ years of relevant experience in statistical programming.
• Experience with Phase I studies and creating ADPP and ADPC datasets.

Responsibilities

• Provide hands-on Statistical Programming expertise for early phase translation medicine.
• Create ADaM safety datasets and NONMEM datasets.

Skills

SAS

CDISC

Statistical Programming

PKPD

Education

Bachelor’s Degree in Statistics

Bachelor’s Degree in Computer Sciences

Bachelor’s Degree in Bioinformatics

Job description

Principal Statistical Programmer, Early Phase

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Principal Statistical Programmer, Early Phase

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Principal Statistical Programmer

Location: home-based anywhere in the United States or Canada

Why IQVIA

Data Sciences Staffing Solutions, DSSS or DS3, is a unit within IQVIA that provides our sponsors with dedicated resources through a Functional Service Provider (FSP) partnership. This allows you to work within a sponsor environment while enjoying the benefits of an industry-leading CRO. Being part of DSSS means contributing to advancing medicine and reshaping healthcare, with a role that is both challenging and rewarding.

Job Responsibilities:

1. Provide hands-on Statistical Programming expertise for the client's early phase translation medicine group.
2. Create ADaM safety datasets such as ADSL, ADLB, ADVS, ADEX, ADPC (concentration), ADPP (parameter), and POPPK (NONMEM) datasets, PK non-compartmental (NCA) tables, figures, and listings (TFLs).
3. Experience with Phase I studies, exposure response analysis, crossover design, and pooling of PK parameters is required.
4. Possess strong SAS technical skills and in-depth CDISC knowledge.
5. Have good knowledge of regulatory requirements for submissions.

Required Experience:

1. Bachelor’s Degree in Statistics, Computer Sciences, Bioinformatics, or related field, with 10+ years of relevant experience.
2. Recent experience working on Phase 1 studies with PKPD data and creating ADPP and ADPC datasets.
3. Hands-on experience creating NONMEM datasets is strongly preferred but candidates with exposure/knowledge of the process and in-depth work in PKPD/Phase 1 studies will be considered.
4. Project/Study lead experience is strongly preferred but not mandatory.

IQVIA is a leading global provider of clinical research services, insights, and healthcare intelligence. We aim to accelerate development and commercialization of medical treatments to improve patient outcomes worldwide. Learn more at https://jobs.iqvia.com

IQVIA is an equal opportunity employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected categories. More info at https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $106,200 - $218,000. Actual offers may vary based on qualifications, location, schedule, and additional compensation benefits.

Seniority level

• Not Applicable

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• Pharmaceutical Manufacturing

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