Be an early applicantLess than 25 applicants

Company

IQVIA · 3 days ago

Principal Statistical Programmer, FSP

Durham, NC

Full-time

Remote

Lead/Staff

$106K/yr - $218K/yr

8+ years exp

Maximize your interview chances

AnalyticsHealth Care

H1B Sponsor Likely

Insider Connection @IQVIA

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

Responsibilities

Translate study protocol and Statistical Analysis Plan into algorithms and specifications to achieve analysis and CDISC standards

Create and/or validate all safety and efficacy study output requirements (e.g. SDTM, ADaM, TLFs) consistent with data definitions and specifications and relevant study documentation (e.g. protocol, SAP, aCRF).

Manage and maintain programming specifications for SDTM, ADaM, analysis dataset, analysis outputs, and integration of data in support of ISS/ISE

Communicate an understanding of statistical programming concepts, basic clinical principles and act in accordance with those principles

Review for consistency across studies within a project; assist with developing project conventions and verifying that conventions are followed

Provide accurate and timely responses to routine requests from clients and with limited supervision responses to non-routine requests from clients

Responsible for identifying opportunities for productivity improvements and formulating proposal for new SAS utilities/macros and their implementation.

Responsible for developing and maintaining good client relationships.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

SAS programmingStatistical programmingSDTMADaMDefine.xmlPinnacle 21SAS Macro programmingSAS SQLPharmaceutical clinical developmentXMLRTFPDFInnovative skills

Required

8 years or more in SAS programming for clinical trial data, working within a CRO or Sponsor environment.

3 years or more working as a study lead for statistical programming activities (to be considered for principal level).

Bachelor’s degree in Math, Stats, Computer Science, Biology, Pharmacy or related.

Programming experience of SDTM and ADaM datasets, both production and validation - exposure with both safety and efficacy domains.

Knowledge in the creation of define.xml, Pinnacle 21, aDRG, and sDRG.

Work independently, exercise good judgment in interpreting, modifying, and adapting company standards, project specifications, tasks, and goals.

Strong knowledge of pharmaceutical clinical development (i.e. understanding of safety deliverables and efficacy analysis supporting regulatory submissions).

Knowledge of base SAS, proc report, exposure to macros, current CDISC data structures, and standardization methodology; demonstrated ability to debug SAS programs.

High degree of technical competence in SAS Macro programming, SAS SQL, XML, RTF, and PDF.

Demonstrated teamwork, pride of ownership, accountability, problem-solving and innovative skills.

Reflect company culture through actions, attitude, and work.

Benefits

Incentive plans

Bonuses

Health and welfare and/or other benefits

Company

IQVIA

Glassdoor

3.9

IQVIA provides analytics, compliance, and management solutions to the life sciences industry.

Founded in 1982

Danbury, Connecticut, USA

10,001+ employees

https://www.iqvia.com

H1B Sponsorship

IQVIA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (218)

2022 (199)

2021 (286)

2020 (197)