Job Title: Principal Statistical Programmer
Location: Available in 3 locations Bangalore, Mumbai , Pune
Category: Clinical
Job ID: 2444693
Company Overview:
Fortrea is a leading global contract research organization (CRO) with a strong commitment to scientific rigor and extensive clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in approximately 100 countries, we are transforming drug and device development globally, aiming to deliver life-changing therapies to patients.
For more information about Fortrea, visit: www.fortrea.com
Job Description:
The Principal Statistical Programmer will perform the role of Lead Statistical Programmer, taking on key responsibilities across various programming activities in clinical trials.
Key Responsibilities:
Leadership & Planning: Lead and oversee all programming activities in a study, including resource estimation, working within budget, meeting timelines, ensuring quality, and coordinating with other departments and clients.
Programming & QC: Develop and maintain SAS programs for SDTM and ADaM datasets, TFLs, and perform quality checks on datasets and TFLs.
Documentation & Analysis: Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs, and Reviewers Guides to support SDTM and ADaM datasets.
Specification Development: Develop or lead the development of complex specifications for SDTMs and ADaM datasets. Contribute to Fortrea and Client standards development.
Study Support: Review SAPs and TFL shells, providing programming insights, and advising on the development of complex TFL shells.
Mentoring: Mentor less-experienced programmers, ensuring adherence to department practices, and foster knowledge sharing at department meetings.
Audit & Compliance: Respond to QA and client audits, supporting qualification audits.
Proposal & Business Development: Contribute to proposal activities, participate in bid defense meetings, and support new business efforts.
Continuous Improvement: Identify and suggest improvements for the efficiency, quality, and productivity of statistical programming.
Required Skills & Qualifications:
Strong experience in SAS programming.
Expertise in developing SDTM, ADaM datasets, and TFLs.
Proven ability to lead and mentor teams in a clinical programming environment.
Ability to interact with multiple departments and clients.
Experience with QA and audit responses in clinical trials.
Knowledge of the latest programming standards and best practices.
Experience in proposal activities and business development.
Fortrea's Culture & Values:
At Fortrea, we are committed to creating an inclusive and diverse workplace. Our Fortrea FOUR culture is based on the following principles:
Forward Together
Own It
Uphold Integrity
Respect People
We believe in a collaborative workspace that encourages personal growth, enabling employees to make a meaningful impact globally.
Equal Opportunity Employer:
Fortrea is proud to be an Equal Opportunity Employer (EOE/AA). We strive for diversity and inclusion and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications. We encourage all qualified individuals to apply.
Accommodation Requests:
If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview, or participate in the hiring process, please contact us at:
Email: taaccommodationsrequest@fortrea.com
(Note: This email address is only for accommodation requests, not for checking the status of applications.)
For more detailed information on our recruitment policies, visit Fortrea's Privacy Statement.
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