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Parexel

Statistical Programmer II

Posted Yesterday
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In-Office or Remote
Hiring Remotely in Hyderabad, Telangana
Entry level
In-Office or Remote
Hiring Remotely in Hyderabad, Telangana
Entry level
Produces and quality-controls clinical trial datasets, tables, figures, and listings using SAS. Supports project start-up, documentation, regulatory submissions, SOP compliance, audits, and process improvements. Maintains knowledge of CDISC, ICH-GCP, 21 CFR Part 11, and international regulations. Provides training and mentorship while collaborating with global teams and meeting quality and delivery objectives.
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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.

About Parexel:

Parexel is a leading global clinical development partner delivering insight driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

About the Role:

We are seeking a Statistical Programmer II to join our team in a Remote capacity. As a Statistical Programmer II, you will support clinical research activities through the analysis and reporting of clinical study data. This role plays an important part in ensuring the quality, accuracy, and regulatory compliance of statistical programming deliverables that support the development of new therapies for patients.   

You will work independently across a range of statistical programming activities and may serve as a Statistical Programming Coordinator on assigned projects. In this role, you will collaborate with sponsors, Data Operations Leads, and cross functional teams while acting as a key contact for statistical programming activities. Responsibilities include producing and quality checking derived datasets and TLFs, supporting data standards and regulatory requirements, maintaining study documentation, and contributing to programming process improvements.   

You will join a fast paced, growth-oriented environment where your technical expertise contributes directly to high-quality clinical research outcomes. With opportunities to expand your knowledge of SAS, clinical data standards, and statistical programming processes, this role offers a meaningful opportunity to grow your career while helping advance the development of innovative therapies.   

Key Responsibilities:

  • Work independently to support programming activities related to the analysis and reporting of clinical study data.   
  • Perform the Statistical Programming Coordinator role on projects and serve as a key contact for statistical programming issues.   
  • Collaborate with sponsors, Data Operations Leads, and other cross functional partners to support study deliverables.   
  • Use efficient programming techniques to produce and quality check derived datasets and tables, listings, and figures.   
  • Create and modify standard macros and applications to improve programming efficiency and consistency.   
  • Support programming activities using SAS and related technologies in accordance with established standards and processes.   
  • Maintain study documentation and support materials in accordance with WSOPs and applicable guidelines.   
  • Apply regulatory and industry technical standards to programming deliverables.   
  • Develop broader knowledge of SAS, statistical programming methodologies, and related processes.   
  • Provide training and mentoring support to staff and project teams as appropriate.   

You’ll thrive in this role if you bring:

  • Strengths in SAS programming, statistical reporting, and technical problem solving.   
  • Experience working in clinical research or a regulated environment.   
  • The ability to collaborate across teams and communicate clearly with stakeholders.   
  • Strong attention to detail and a commitment to quality.   
  • Comfort working with clinical study data, programming standards, and reporting processes.   

Required Qualifications:

  • Graduate or Master's degree in a relevant field such as life sciences, computer science, pharmacy, or a related discipline, or equivalent experience.   
  • Proficiency in SAS and knowledge of programming and reporting processes.   
  • Knowledge of WSOPs, ICH-GCP, and System Life Cycle methodologies.   
  • Ability to manage complex projects and adapt effectively to changing business needs.   
  • Competent written and verbal English communication skills.   

Preferred Qualifications:

  • 3+ years of experience in end to end programming (SDTM, ADaM & TLFs).   
  • Experience creating programming efficiencies through standard macros and applications.   

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