Statistical Programmer (Immunology)

Allergan; North Chicago (IL); On-site; USD 92,000 - 119,000; Full time

Job summary

An established industry player is seeking a skilled statistical programmer to join their team. In this role, you will be responsible for developing and validating ADaM datasets, ensuring compliance with CDISC standards, and creating documentation for regulatory filings. This position offers the opportunity to work on impactful projects that directly contribute to advancing healthcare solutions. If you are passionate about data analysis and thrive in a collaborative environment, this role could be your next career step in the pharmaceutical industry.

Benefits

Paid time off

Medical insurance

Dental insurance

Vision insurance

401(k)

Short-term incentive programs

Long-term incentive programs

Qualifications

• 2 years of statistical programming experience in the pharmaceutical industry.
• Experience with developing and validating ADaM datasets.

Responsibilities

• Create specifications for ADaM data sets for clinical studies.
• Develop SAS programs for creation & validation of ADaM data sets.

Skills

SAS Enterprise Guide

SAS Studio

SAS BASE

SAS STAT

SAS ODS

Statistical programming

CDISC standards

Regulatory documentation

Education

BS in Statistics

MS in Statistics

Tools

SAS Macros

SAS procedures

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Key Responsibilities

1. Create specifications for the structure of ADaM data sets for individual studies.
2. Develop SAS programs for creation & validation of ADaM data sets following CDISC standards, & of Tables, Listings & Figures.
3. Ensure accuracy of SAS programs by reviewing code, log & output files.
4. Review output to ensure consistency with output for other activities (CSR, ISS, ISE).
5. Create documentation for regulatory filings including reviewers guides & data definition documents.
6. Participate in development of SAS Macros.

Qualifications

Education & Experience

Must possess a BS or foreign academic equivalent in Statistics, Biostatistics, Computer Science or a related field & 2 years of statistical programming experience analyzing clinical trial data in the pharmaceutical industry. Of experience required, must have 2 years of work experience in the following:

1. developing, reviewing & executing code using SAS Enterprise Guide &/or SAS Studio;
2. performing programming tasks including data processing & manipulation using SAS BASE, data analysis using SAS STAT, & data reporting using SAS ODS;
3. using SAS macro variables & macro functions including debugging the macro;
4. developing & validating programming code for derivation of key variables in Trial Design SDTM domains;
5. developing & validating ADaM datasets in compliance with CDISC standards & developing Tables, Listings, & Figures;
6. developing & validating programming code using SAS procedures to implement statistical methodologies for analysis of categorical & continuous variables including linear regression, categorical data analysis, survival analysis, & significance testing;
7. creating or reviewing documentation for regulatory filings including reviewers’ guides & data definition documents; &
8. complying with FDA, EMA, & other regulatory agencies/ICH guidelines & relevant regulatory requirements.

Alternatively, would accept a MS in Statistics, Biostatistics, Computer Science or a related field or foreign academic equivalent, & 6 months of statistical programming experience. Of experience required, must have 6 months in each of i. through viii.

Experience may be gained concurrently. Any suitable combination of education, training or experience is acceptable.

Additional Information

Salary Range: $92,820.00 - $118,500.00 per year.

Apply online at https://careers.abbvie.com/en. Refer to Req ID: REF38574A

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We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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