Principal Statistical Programmer

0-2 years

Not Disclosed

Bangalore Mumbai Pune

10 Feb. 13, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Principal Statistical Programmer
Available in 3 locations
Category: Clinical
Job ID: 2444693

Description:
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Responsibilities:

Perform the role of the Lead Statistical Programmer.
Plan, execute and oversee all programming activities on a study, including but not limited to resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs.
Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs.
Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Fortrea and Client standards.
Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective.
Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs ensuring adherence to department practices and processes.
Present and share knowledge at department meetings.
Respond to QA and client audits and support qualification audits.
Contribute to proposal activities and participate in bid defense meetings in order to win new business.
Continually identify and suggest ways to improve the efficiency, quality, and productivity of statistical programming.
Perform all other duties as needed or assigned.

About Fortrea:
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview, or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.

Slug: principal-statistical-programmer

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Principal Statistical Programmer

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