Senior Manager, Statistical Programming

Initial Therapeutics, Inc.

Irvine (CA)

On-site

USD 120,000 - 150,000

Full time

14 days+

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Benefits offered by this job

Comprehensive benefits package

401(k) plan for eligible employees

Short-term and long-term incentive programs

Job summary

A leading biopharmaceutical company is seeking a Senior Manager of Statistical Programming to oversee and lead a talented team in developing statistical methodologies for new products. This leadership position requires strong SAS programming skills, experience in regulatory processes, and a solid background in statistics. Role involves ensuring quality and consistency in programming activities while developing staff through mentorship and career planning.

Qualifications

MS in Statistics/Computer Science with 9+ years of experience or BS with 11+ years.
Minimum 2 years experience in a leadership role in statistical programming.
In-depth understanding of SAS programming and CDISC standards.

Responsibilities

Leads statistical programming for multiple compounds or a therapeutic area.
Manages and mentors a team of programmers.
Ensures timely deliverables and quality processes are followed.

Skills

SAS Programming

Team Leadership

Communication

Regulatory Knowledge

Education

MS in Statistics

BS in Statistics

Job description

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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 atwww.abbvie.com . Follow @abbvie onX ,Facebook ,Instagram ,YouTube ,LinkedIn andTik Tok .

Company Description

Job Description

Purpose

The Senior Manager of Statistical Programming is a leadership role which manages a team of statistical programmers in the research and development of new pharmaceutical products. The Senior Manager of Statistical Programming is responsible for leading the statistical programming activities for one or more compounds/indications or a therapeutic area. This role must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations.

Responsibilities

Leads the statistical programming activities for one or more compounds/indications or a therapeutic area.
Manages a team of statistical programmers and the resource planning for their assigned projects.
Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
Ensures consistency 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 the development of standard operating procedures.
Manages, mentors and creates career development plans for assigned staff.
Participates in the recruitment and selection of new staff.

Qualifications

*This position will be required to sit on-site 3 days / week*

Qualifications

MS in Statistics, Computer Science or a related field with 9+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience.
Minimum of 2 years experience leading a team of statistical programmers.
In-depth understanding of SAS programming concepts and techniques related to drug development.
In-depth understanding of CDISC Standards.
In-depth understanding of the drug development process, including experience with regulatory filings.
Ability to communicate clearly both oral and written.
Ability to effectively represent the Statistical Programming Organization in cross functional teams.
Ability to accurately estimate effort required for project related programming activities.

Key Stakeholders

Directors of Statistics
Data Scientists
Medical Writers
Regulatory Publishers
Clinical Project Managers

Additional Information

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

The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
This job is eligible to participate in our short-term incentiveprograms.
This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable 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 AbbVies 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, visithttps://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

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