Statistical Programmer II

Posted 9 Days Ago
Be an Early Applicant
Newton, MA, USA
In-Office
116K-132K Annually
Senior level
Pharmaceutical
The Role
The Statistical Programmer II conducts statistical programming for clinical trials, develops SAS programs, creates datasets compliant with CDISC standards, and maintains documentation for regulatory compliance.
Summary Generated by Built In

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job Location: 275 Grove Street, Suite 101C, Newton, MA 02466 and position may telecommute from anywhere in the United States 5 days per week.

Job Title: Statistical Programmer II

Duties: Parexel International LLC seeks a Statistical Programmer II reporting to headquarters in Newton, Massachusetts to conduct statistical programming. Use programming techniques to produce derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings in compliance with CDISC standards. Provide technical expertise for clinical trials and support programming activities related to analysis and reporting of clinical study data. Assist in project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Create define.xml files and reviewer guides for inclusion in regulatory submissions. Use efficient programming techniques to quality control low-medium complexity derived datasets, tables, figures, and data listings. Produce Tables, Listings, and Figures (TLFs) for clinical study reports, regulatory submissions, and publications. Assist in the production and quality control of derived dataset specifications and other process supporting documents and submission documentation. Implement statistical analysis plans (SAPs) by writing SAS code. Provide training and mentorship to staff and project teams. Maintain all supporting documentation for studies in accordance with SOPs and guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs, guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal and external audits and regulatory inspections. Participate in process/quality improvement initiatives and work with P21 Enterprise version. Position may telecommute from anywhere in the United States 5 days per week. Annual salary: $115,790.20 - $132,400.

Requirements: Bachelor’s degree in Statistical Programming, Mathematics, Statistics, Data Analytics, Business Administration, or a related field plus 5 progressive years of statistical programming experience. Must have five years of experience in each of the following: (1) Developing and validating SAS programs for clinical trial data analysis, including data cleaning, data integration, and report generation; (2) Creating and maintaining Analysis Data Model (ADaM) datasets in compliance with CDISC standards; (3) Producing Tables, Listings, and Figures (TLFs) for clinical study reports, regulatory submissions, and publications; (4) Implementing statistical analysis plans (SAPs) by writing SAS code; (5) Performing quality control checks on SAS programs and outputs produced by other team members; (6) Maintaining, and utilizing standard SAS macros and tools, including Base, Stat, Macro, EG, Studio, Graph, ODS, and Report; (7) Creating define.xml files and reviewer’s guides for inclusion in regulatory submissions; (8) Working with ICH-GCP and 21 CFR Part 11.

To apply, please send resume to [email protected] and cite requisition number 00979 or apply at jobs.parexel.com. This position is subject to the company’s Employee Referral Program.

EEO Disclaimer
Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Skills Required

  • Bachelor's degree in Statistical Programming, Mathematics, Statistics, Data Analytics, Business Administration, or a related field
  • 5 years of experience in statistical programming
  • 5 years of experience developing SAS programs
  • 5 years of experience creating ADaM datasets
  • 5 years of experience producing TLFs for clinical reports and submissions
  • 5 years of experience implementing SAPs using SAS
  • 5 years of experience performing quality control checks
  • 5 years of experience maintaining SAS macros and tools
  • 5 years of experience with ICH-GCP and 21 CFR Part 11

Parexel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.

  • Healthcare Strength Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
  • Retirement Support Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
  • Leave & Time Off Breadth Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.

Parexel Insights

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The Company
HQ: Durham, North Carolina
20,524 Employees

What We Do

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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