senior statistical programmer

AbbVie

<div>Company Description 
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. 
Job Description 
The role of the Senior Statistical Analyst is to perform statistical programming activities for all assigned Phase I-IV clinical studies sponsored by AbbVie and its partners. This position performs statistical programming for clinical studies, integrated summaries, and in support of responses to requests from regulatory authorities. This position can serve as a study lead for an assigned study.
Responsibilities:<ul><li>
Leads the statistical programming activities, and provide programming and documentation support for multiple studies with high quality</li><li>
Review statistical analysis plans for all assigned studies and integrated summaries in conjunction with program lead and provide comments to study biostatistician</li><li>
Create ADaM data set specifications and data set for all assigned studies and integrated summaries</li><li>
Ensure study analysis is consistent with standard templates and specifications</li><li>
Contribute to submission support and support urgent regulatory agency requests</li><li>
Follow timelines for assigned study tasks</li><li>
Coordinate own task assignments</li><li>
Participating in a Statistical Programming process improvement initiative</li><li>
Manage timelines and ensure good communication with CROs/FSPs, internal programmers, statistics, data management, medical writing, regulatory publishing and clinical operations.</li><li>
Oversee programming tasks for a single study</li><li>
Conduct high level review of deliverables provided by CRO/FSP to ensure good quality and accuracy</li></ul> 

Qualifications 
Minimum Qualifications:<ul><li>
Degree in Statistics, Mathematics, or Engineering</li><li>
6+ years of relevant experience (with MS). OR 8+ years of relevant experience (with BS).</li><li>
Experience with SAS programming related to drug development</li><li>
Experience with regulatory filings</li><li>
Experience adhering to CDISC standards and creating and reviewing ADaM speicifications</li></ul>
Preferred Qualifications:<ul><li>
Knowledge of R or Ai is not required but can be a plus.</li></ul>
Other Required Skills:<ul><li>
In-depth understanding of SAS programming concepts and techniques related to drug development.</li><li>
Fundamental understanding of CDISC Standards.</li><li>
Fundamental understanding of the drug development process.</li><li>
Ability to communicate clearly both oral and written.</li><li>
Ability to accurately estimate effort required for study related programming activities.</li></ul> 

Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
<ul><li>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 atthe time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors includinggeographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</li><li>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</li><li>This job is eligible to participate in our short-term incentive programs.
</li></ul>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 aparticular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolute discretion,consistent with applicable law.<div></div>
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.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Senior Statistical Analyst - Programmer (Hybrid)

Parexel

<div>Name of Employer: Parexel International LLC
Position Title: Principal Statistical Programmer
Position Location: 275 Grove Street, Newton, MA 02466 
Salary: $159,896.21 &ndash; $207,400 per year
Hours: Full Time / 40 hours per week
Summary of Duties:
Provide technical support and expert advice to internal and external sponsors on statistical programming projects to support clinical trial activities. Work independently to support various programming activities related to analysis and reporting of clinical study data. Fill the Statistical Programming Lead role on projects and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas. Monitor quality, timelines, resource allocation, and productivity in relation to budget. Project management for statistical programming. Advise and negotiate statistical programming timelines.
Education requirements: Bachelor's in Statistics, Mathematics, Pharmaceutical Science, Data Analytics or related field. Employer will accept post-secondary academic coursework and/or relevant work experience which is evaluated as equivalent to a U.S. Bachelor&rsquo;s degree in accordance with 8 CFR &sect; 214.2(h)(4)(iii)(D).
Experience requirements: 7 years of progressive experience in statistical programming.
Special Skills or Other Requirements: Applicants must have 7 years of experience with:
Programming and reporting process; FDA 21 CFR Part 11 regulations; Regulatory requirements (ICH-GCP, CDISC, and electronic submissions); Analyzing data from Phase I, II, and III clinical trials; SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS Data Step, Proc Step, and Functions; Generating reports, tables, and listings for statisticians; Building structured, CDISC, SDTM, or ADaM databases for clinical studies; Leading teams in a statistical programming environment; Pinnacle 21 for CDISC compliance validation; and R programming for statistical analysis and visualization.
*100% Remote reporting to Newton, MA.*
*Position eligible for Employee Referral Program*
To apply: Individuals interested in applying for the position may email a resume with Job #LV0209 to openings@parexel.com.</div>

Principal Statistical Programmer

Johnson & Johnson

<div>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Data Analytics &amp; Computational Sciences
Job Sub Function:
Biostatistics
Job Category:
Scientific/Technology
All Job Posting Locations:
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description:
About Innovative Medicine 
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. 
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for Statistical Programming Lead, located in Spring House, PA, Titusville or Raritan, NJ. 
Purpose: The Statistical Programming Lead is an experienced programmer with an advanced knowledge of programming languages, has expertise in industry standards, complex data structures and programming methods, having the technical capabilities in leading trial activities in accordance with departmental processes and procedures.
This role is responsible for providing expertise, planning and oversight of one or more programming trial activities of moderate to high complexity. The role makes decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables, and provides leadership, direction, and technical guidance to programming teams.
This role develops cross-functional working relationship with stakeholders to shape processes and practices and contributes expertise to Delivery Unit or departmental innovation and process improvement projects. The Senior Programming Lead position combines the expertise and responsibilities in their respective programming roles, making them an asset to IDAR&rsquo;s (Integrated Data Analytics &amp; Reporting) C&amp;SP (Clinical and Statistical Programming) activities. 
You will be responsible for: 
Principal Responsibilities:<ul><li>
Responsible for planning, programming strategy, coordination, oversight, and execution of team activities following J&amp;J IM and industry standards for one or more clinical trials or projects.</li><li>
Designs and develops programs in support of complex clinical data analysis and reporting activities.</li><li>
Supports submission activities including but not limited to creation, verification, and delivery of CDISC compliant and/or non-standard data packages and reviewer&rsquo;s guides.</li><li>
Provides technical and project-specific guidance to team members, ensuring high-quality, efficiency and on-time deliverables in compliance with departmental processes and procedures. Ensures use of latest standards and deployment of current technologies.</li><li>
Collaborates effectively with cross-functional team, counterparts, vendors to achieve project goals and manages escalations independently.</li><li>
Supports submission activities while ensuring the highest level of consistency and quality across trials by creating efficiencies in clinical data flow and implementing metadata-driven approaches.</li><li>
As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality.</li><li>
May play the role of a Delivery Unit/Disease Area Expert contributing to standards strategy and providing expertise for a specific Delivery Unit/Disease area across value streams in support of clinical programs including submissions.</li><li>
Contributes to departmental innovation and process improvement projects by supporting and/or leading developing and implementing processes, systems, and tool improvement initiatives.</li></ul>
Clinical Programming:
<ul><li>Ensures the utilization of latest standards and technologies, adhering to regulatory requirements, and creating effective mapping algorithms and Data Review Model (DRM) and designs mapping algorithms for non-standard conversions as needed.</li><li>
Supports data cleaning by programming edit checks and data review listings and data reporting by creating data visualizations and listings for data management, medical monitoring, and central monitoring.</li></ul>
Principal Relationships:
<ul><li>This role reports into a people manager position within the Delivery unit and is accountable to the Portfolio Lead for assigned activities and responsibilities.</li><li>
Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations.</li><li>
Functional Contacts within J&amp;J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources.</li><li>
External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups.</li></ul> 
Qualifications / Requirements: 
Education: Bachelor&rsquo;s degree or higher and/or equivalent in computer science, mathematics, data science/analytics/data engineering, public health, or other relevant scientific field (or equivalent theoretical/technical depth).
Experience and Skills Required:
<ul><li>4+ years programming and or clinical data management experience with increasing responsibility in pharmaceutical/clinical trial environment.</li><li>
Knowledge of programming practices (including tools and processes).</li><li>
Knowledge of data structures and relevant programming languages for data manipulation/statistical analysis and reporting such as SAS and R experience are required.</li><li>
Experience working with cross functional stakeholders and teams.</li><li>
Project management skills and knowledge of team management principles.</li><li>
Working knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&amp;D concepts are required.</li><li>
Demonstrated written and verbal communication skills.</li></ul>
Experience and Skills Preferred:
<ul><li>Python is preferred.
</li><li>Expert CDISC Standards knowledge is preferred.</li><li>
Experience in planning and coordinating programming activities and leading teams.</li><li>
Experience in vendor management oversight will be nice to have.</li></ul>
#LI-Hybrid
The expected base pay range for this position is $ 109,000.00 - $174,800.00 
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation&rsquo;s performance over a calendar/performance year. Bonuses are awarded at the Company&rsquo;s discretion on an individual basis. 
<ul><li>Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.</li><li>
Subject to the terms of their respective plans, employees are eligible to participate in the Company&rsquo;s consolidated retirement plan (pension) and savings plan (401(k)).</li><li>
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits:</li><li>
Vacation &ndash;120 hours per calendar year</li><li>
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington &ndash;56 hours per calendar year</li><li>
Holiday pay, including Floating Holidays &ndash;13 days per calendar year</li><li>
Work, Personal and Family Time - up to 40 hours per calendar year</li><li>
Parental Leave &ndash; 480 hours within one year of the birth/adoption/foster care of a child</li><li>
Condolence Leave &ndash; 30 days for an immediate family member: 5 days for an extended family member</li><li>
Caregiver Leave &ndash; 10 days</li><li>
Volunteer Leave &ndash; 4 days</li><li>
Military Spouse Time-Off &ndash; 80 hours 
</li></ul>Additional information can be found through the link below.
For additional general information on Company benefits, please go to:<ul><li>
https://www.careers.jnj.com/employee-benefits 
 
</li></ul>The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. 
This job posting is anticipated to close on 4/18/2026. The Company may, however, extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Advanced Analytics, Biostatistics, Clinical Trials, Collaborating, Consulting, Critical Thinking, Data Privacy Standards, Data Quality, Data Savvy, Digital Fluency, Good Clinical Practice (GCP), Quality Assurance (QA), Report Writing, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Statistics, Systems Development, Technologically Savvy</div>

Statistical Programming Lead

<div>Company Description 
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. 
Job Description 
The Associate Director provides statistical programming support for multiple clinical projects across multiple therapeutic areas, both through individual contribution and through the work of staff. The Associate Director provides training and performance management for staff. The Associate Director demonstrates leadership competencies, builds relationships, and promotes teamwork within the Statistical Programming organization and across functions. The Associate Director is accountable for ensuring statistical programming support is delivered across multiple therapeutic areas. The Associate Director makes key recommendations and decisions related to processes, standards, and resource management. The Associate Director is also responsible for staff management and development.
Responsibilities:<ul><li>
SAS Programming: Demonstrates a strong understanding of SAS programming concepts and techniques used in the pharmaceutical industry and applies that knowledge to resolve non-routine problems.</li><li>
Standards: Oversees the development and implementation of global company standards for output design and programming conventions and monitors regulatory guidance and industry best practices.</li><li>
CRFs and Database Definitions: Provides strategic guidance on CRF and database design and reviews global standards related to these deliverables.</li><li>
Derivation Programming, Submission Data Sets, and Programs: Interprets statistical analysis plans, develops analysis data set specifications, and oversees the development and implementation of global standards for derived data sets and submission programs.</li><li>
Cross-Functional Collaboration: Works collaboratively with stakeholders to manage priorities and resources across therapeutic areas. Demonstrates a solid understanding of drug development principles, anticipates risks, develops contingency and escalation plans, and contributes to cross-functional initiatives.</li><li>
Communication: Presents statistical programming concepts, risk assessments, and recommendations clearly and persuasively to statisticians, scientists, programmers, and non-scientists. Effectively leads meetings and presentations.</li><li>
Training and Mentoring: Provides guidance, training, and mentoring to staff to support development and ensure compliance with training requirements.</li><li>
Staff Management: Assigns responsibilities, defines scope, and reviews progress to ensure projects are delivered on time and with appropriate quality. Allocates resources to maintain the right balance of expertise across projects and collaborates with management to assess staffing needs. Sets high expectations, promotes open communication, and leads staff to meet organizational goals. Provides performance management for 4&ndash;10 statistical programmers.</li></ul> 

Qualifications 
Minimum Qualifications:<ul><li>
Degree in Statistics, Computer Science, or a related field</li><li>
10+ years of statistical programming experience (with MS) OR 12+ years of statistical programming experience (with BS)</li><li>
Strong technical competence in SAS programming and macro development.</li><li>
Experience in pharmaceutical clinical trials.</li><li>
Experience with regulatory filings such as NDA, BLA, or other submissions, including ISS and ISE experience.</li></ul>
Preferred Qualifications:<ul><li>
Experience interacting with regulatory agencies, especially FDA and EMEA.</li><li>
Previous management experience.</li></ul>
Other Required Skills:<ul><li>
Working knowledge of ICH guidelines and relevant regulatory requirements.</li><li>
Strong oral and written communication skills.</li></ul> 

Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
<ul><li>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.
</li><li>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</li><li>This job is eligible to participate in our long-term incentive programs.
</li></ul>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&rsquo;s sole and absolute discretion, consistent with applicable law.<div></div>
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.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Associate Director - Statistical Programming (Hybrid)

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