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Lead, Statistical Programming

3+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Remote 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

Join Our Growing Team at Biorasi!

At Biorasi, we are passionate about driving new therapies to patients. As a dynamic, innovative, and collaborative full-service clinical research organization, we are committed to supporting your career journey while fostering a strong work-life balance. We offer a thriving, fast-paced environment where you can capitalize on your strengths and develop your career within the expanding clinical research industry.

We are looking for talented individuals – whether you’re an experienced clinical trial professional or new to the industry – who are excited about making an impact in clinical research. This is your chance to be part of an award-winning, global company that is changing the way we deliver clinical trials.

Your Role:

  • Ensure high-quality outputs that meet project requirements and standards.
  • Oversee well-organized, up-to-date project documentation, and maintain inspection readiness.
  • Review and provide feedback on study documents such as protocols, eCRFs, datasets, SAPs, and mock shells.
  • Develop and maintain standard programs, macros, templates, and libraries for statistical programming.
  • Contribute to project-specific objectives and deliverables.
  • Manage on-time delivery for concurrent programming deliverables.
  • Tackle complex statistical programming challenges and guide teams towards solutions.
  • Develop annotated CRFs and regulatory submission documentation, including Define.xml and data reviewer’s guides.
  • Create programming specifications in alignment with client requirements and CDISC standards.
  • Develop and validate CDISC-compliant datasets (SDTM/ADaM) and Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
  • Act as a secondary contact for sponsors, vendors, and the project team for study-related programming activities.
  • Review and approve electronic Case Report Forms (eCRFs) as needed.
  • Lead and mentor small teams of internal and consultant programmers to drive project progress.
  • Maintain professionalism, productivity, and high-quality standards.
  • Participate in regulatory training, ICH GCP, and 21 CFR Part 11 compliance.
  • Perform additional statistical programming tasks as required.

Your Profile:

  • Bachelor’s Degree in Mathematics, Statistics, Life Sciences, Computer Science, or related field (or equivalent experience).
  • Fluent in English (both oral and written).
  • At least 3 years of experience in Biostatistics or Statistical Programming within the pharmaceutical industry or a related field.
  • Experience in planning, coordinating, and leading programming activities is a plus.
  • Strong multitasking, prioritization, and attention to detail.
  • Problem-solving and leadership skills to drive practical solutions.
  • Excellent team collaboration in cross-functional environments.
  • Solid understanding of drug development and clinical research processes.
  • Familiarity with ICH GCP and global regulatory requirements.
  • Ability to thrive in a fast-paced environment with excellent time management and planning skills.
  • Strong written and verbal communication skills.

If you are passionate about clinical research and meet the qualifications above, we invite you to apply directly at biorasi.com or email us at careers@biorasi.com.

Benefits: Biorasi offers competitive benefits to enhance the health and well-being of our employees and their families, including:

  • Half-day Fridays
  • Paid time off and holidays
  • Country-specific benefits and employee bonus programs
  • Career growth opportunities and training
  • A supportive, collaborative, and creative team culture

Biorasi is an equal opportunity employer committed to diversity and inclusion. All qualified applicants will be considered for employment regardless of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We are also dedicated to ensuring compliance with fair employment practices regarding citizenship and immigration status.