Lead, Statistical Programming

3+ years

Not Disclosed

Remote

10 Dec. 24, 2024

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

Job Opportunity: Statistical Programmer
Company: Biorasi

About Biorasi
Biorasi is an award-winning, full-service clinical research organization committed to advancing clinical trials. We foster an innovative, collaborative, and dynamic work culture, offering employees the opportunity to thrive in the expanding clinical research industry while achieving work-life balance.

Your Role

As a Statistical Programmer, you will play a vital role in ensuring the quality and efficiency of statistical programming activities, supporting clinical study reports, regulatory submissions, and publications. Key responsibilities include:

Ensuring outputs meet quality standards and project requirements.
Maintaining well-organized and up-to-date project documentation for inspection readiness.
Reading and interpreting study documents (protocols, eCRFs, dataset specifications, SAP, etc.) and providing feedback.
Developing and maintaining standard programs, macros, templates, and libraries for statistical programming.
Delivering project-specific objectives and team deliverables on time.
Resolving complex statistical programming challenges and providing team guidance.
Developing annotated CRFs, Define.xml, and data reviewer guides for regulatory submissions.
Creating programming specifications compliant with CDISC standards to support clinical study reports.
Developing and validating CDISC-compliant datasets (SDTM/ADaM) and TLFs based on study specifications.
Acting as a backup contact for sponsors, vendors, and project teams.
Reviewing and approving electronic Case Report Forms (eCRFs) as required.
Leading small programming teams to ensure progress on deliverables.
Undergoing regulatory training, including ICH GCP and 21 CFR Part 11.

Your Profile

Education: Bachelor’s Degree in Mathematics/Statistics, Life Sciences, Computer Science, or related field (or equivalent experience).
Experience: Minimum 3 years in Biostatistics or Statistical Programming in the pharmaceutical industry or related field.
Skills:
- Experience leading programming teams and coordinating activities preferred.
- Strong multitasking and prioritization skills.
- Excellent attention to detail, quality, and timeliness.
- Problem-solving and leadership capabilities with practical, creative solutions.
- Strong knowledge of drug development, clinical research, ICH GCP, and regulatory requirements.
- Excellent communication (verbal and written) and team collaboration skills.
- Proficiency in working in fast-paced environments.

Why Join Biorasi?

We prioritize the well-being of our employees with thoughtfully designed benefits, including:

Half-day Fridays.
Paid time off and holidays.
Comprehensive country-specific benefits.
Employee bonus programs.
Career growth opportunities, training, and development.

Apply Now

If you’re ready to join a creative, energetic, and collaborative team, apply at our Careers Page or email us at careers@biorasi.com.

Diversity and Inclusion

Biorasi is committed to creating an inclusive environment and is proud to be an equal opportunity employer. All qualified applicants will be considered regardless of race, color, religion, gender, sexual orientation, national origin, age, disability, or veteran status. Join us and contribute to driving innovation in clinical research while advancing your career.

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Lead, Statistical Programming

Job Description

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