Senior Associate, Statistical Programming

Biorasi

2+ years

Not Disclosed

Remote, USA

10 Dec. 11, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Statistical Programmer
Location: Remote (Global)
Employment Type: Full-time
Posted: 12/11/2024

About Biorasi:

At Biorasi, we are rapidly expanding, offering an innovative, dynamic, and evolving environment. As an award-winning, customer-focused, full-service clinical research organization, we empower your career growth while promoting work-life balance. We're looking for passionate individuals to join our team—whether you're a clinical trial veteran or new to clinical research. This is your opportunity to be a vital part of a growing global company driving new therapies to patients.

Your Role:

As a Statistical Programmer, you will contribute to creating high-quality outputs that meet project requirements. Key responsibilities include:

Creating outputs that meet quality standards and project requirements.
Maintaining well-organized, up-to-date project documentation and ensuring inspection readiness.
Reading and understanding study documents (Protocol, eCRF, Dataset specifications, SAP, Mock shells) and providing feedback.
Contributing to project-specific objectives and team deliverables.
Managing on-time delivery of concurrent programming tasks.
Developing annotated CRFs and regulatory submission documentation (Define.xml, data reviewer’s guides).
Learning to develop programming specifications compliant with client requirements and CDISC standards.
Developing and validating CDISC-compliant datasets (SDTM/ADaM) and TLFs, supporting clinical study reports, regulatory submissions, and publications.
Maintaining a high level of professionalism, performance, and quality.
Undergoing regulatory training (ICH GCP, 21 CFR Part 11) and other related trainings.
Other statistical programming duties as assigned.

Your Profile:

Education: Bachelor’s Degree in Mathematics/Statistics, Life Sciences, Computer Science, or related field.
Experience: At least 2 years of experience in Biostatistics or Statistical Programming within the pharmaceutical industry or a related field.
Skills:
- Ability to multitask and prioritize work with strong attention to detail, timeliness, and quality.
- Strong problem-solving and leadership skills, capable of contributing creative and practical solutions.
- Excellent teamwork and communication skills, both written and verbal.
- Significant knowledge of drug development, clinical research, and ICH GCP guidelines.
- Ability to work in a fast-paced environment and effectively manage time.

Why Biorasi?

Employee Benefits: Half-day Fridays, paid time off, paid holidays, employee bonus programs, career growth, and training opportunities.
Diversity and Inclusion: Biorasi is committed to creating a diverse and inclusive environment and is an equal opportunity employer.

Apply Now:

If you're ready to join an energetic, creative, and collaborative team, apply directly on our website at Biorasi Careers or email us at careers@biorasi.com.

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Senior Associate, Statistical Programming

Job Description

About Biorasi:

Your Role:

Your Profile:

Why Biorasi?

Apply Now:

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