Senior Statistical Analyst

Initial Therapeutics, Inc.; Branchburg Township (NJ); Remote; USD 80,000 - 110,000; Full time

Job summary

An innovative pharmaceutical company is seeking a Senior Statistical Analyst to lead statistical programming for clinical trials. This role is pivotal in analyzing and reporting clinical data, ensuring compliance with CDISC standards, and mentoring junior team members. You will work closely with various departments to drive the development of new pharmaceutical products that can significantly impact patient lives. If you are passionate about statistics and drug development, this is an exciting opportunity to contribute to groundbreaking work in a collaborative and supportive environment.

Benefits

Paid time off

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Short-term incentive programs

Qualifications

• 6+ years of experience in statistical analysis and programming.
• In-depth knowledge of SAS and CDISC standards.

Responsibilities

• Lead statistical programming activities for clinical studies.
• Develop SAS programs for ADaM datasets and regulatory documents.

Skills

SAS Programming

Statistical Analysis

Communication Skills

Regulatory Filings Knowledge

Education

MS in Statistics or related field

BS in Statistics or related field

Tools

SAS

CDISC Standards

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, as well as products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and Tik Tok.

Job Description

The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for clinical studies and projects with lower complexity. The Senior Statistical Analyst interfaces with Statistics, Data Sciences, Medical Writing, Regulatory Publishing, and Clinical Operations.

• Leads the statistical programming activities for projects with lower complexity.
• Leads the statistical programming activities for studies.
• Develops SAS programs for the creation of ADaM data sets following CDISC standards.
• Develops SAS programs for the creation of Tables, Listings, and Figures.
• Validates ADaM data sets, Tables, Listings, and Figures.
• Creates specifications for the structure of ADaM data sets for individual studies and integrated data.
• Creates documentation for regulatory filings including reviewers' guides and data definition documents.
• Leads the development of standard SAS Macros and participates in the development of standard operating procedures.
• Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts.

Qualifications

• MS in Statistics, Computer Science or a related field with 6+ years of relevant experience, OR BS in Statistics, Computer Science or a related field with 8+ years of relevant experience.
• In-depth understanding of SAS programming concepts and techniques related to drug development.
• Fundamental understanding of CDISC Standards.
• Fundamental understanding of the drug development process, including experience with regulatory filings.
• Ability to communicate clearly both orally and in writing.
• Ability to accurately estimate effort required for study-related programming activities.

This is a remote opportunity and can be hired anywhere in the US.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• 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 incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html