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Senior Associate, Statistical Programming

2+ 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’re passionate about delivering new therapies to patients, and we are looking for top performers who share that passion. Whether you're a seasoned clinical trial professional or new to the field, we offer a fast-paced, innovative, and collaborative environment where you can thrive and develop your career in the expanding clinical research industry.

Why Biorasi? We are a dynamic, evolving, award-winning, full-service clinical research organization, known for our commitment to excellence and customer focus. Our culture values innovation and work-life balance, and we are dedicated to helping you capitalize on your strengths as you grow professionally.

Your Role:

  • Ensure the creation of outputs that meet quality standards and project requirements.
  • Maintain organized, up-to-date project documentation and verification/quality control documents to ensure inspection readiness.
  • Review study documents (Protocol, eCRF, Dataset specifications, SAP, Mock shells, etc.) and provide feedback when necessary.
  • Contribute to achieving project-specific objectives and team deliverables.
  • Manage on-time delivery across concurrent programming deliverables.
  • Develop annotated CRFs and regulatory submission documentation, including Define.xml and data reviewer’s guides.
  • Learn to develop programming specifications compliant with CDISC standards, and create programming plans for statistical outputs supporting clinical study reports, regulatory submissions, and publications.
  • Develop and validate CDISC-compliant datasets (SDTM/ADaM) and Tables, Listings, and Figures (TLFs).
  • Uphold professionalism, productivity, and high-quality standards across all tasks.
  • Participate in regulatory training, ICH GCP, and 21 CFR Part 11 compliance training.
  • Take on other statistical programming duties and responsibilities as assigned.

Your Profile:

  • Bachelor’s Degree in Mathematics/Statistics, Life Sciences, Computer Science, or a related field.
  • Fluent in English (oral and written).
  • At least 2 years of experience in Biostatistics or Statistical Programming within the pharmaceutical industry or related field.
  • Experience in planning and coordinating programming activities, with a preference for candidates with leadership experience.
  • Strong ability to multitask and prioritize work with attention to detail, timeliness, and quality.
  • Strong problem-solving skills and the ability to contribute creative and practical solutions.
  • Excellent teamwork capabilities, able to work well in cross-functional teams.
  • Good knowledge of drug development and clinical research.
  • Understanding of ICH GCP and applicable worldwide regulatory requirements.
  • Ability to thrive in a fast-paced environment.
  • Excellent time management, planning, and communication skills.

If you are looking to join a creative, energetic, and collaborative team, and meet the qualifications above, we encourage you to apply directly on our website at biorasi.com or email us at careers@biorasi.com.

Benefits: At Biorasi, we offer a range of benefits designed to enhance your health and well-being, including:

  • Half-day Fridays
  • Paid time off and holidays
  • Country-specific benefits and employee bonus programs
  • Opportunities for career growth, training, and development

Biorasi is an Equal Opportunity Employer. We are committed to fostering a diverse environment and ensuring that all qualified applicants are given equal consideration for employment, regardless of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We also comply with all fair employment practices regarding citizenship and immigration status.