Senior Scientist, Biostatistics

Senior Scientist, Biostatistics

Reporting to Executive Director, Biostatistics under Clinical Data Sciences (CDS), the Senior Scientist, Biostatistics is responsible for leading the statistical activities of the clinical development plan and providing scientifically rigorous statistical solutions and strategic inputs on various clinical development activities including clinical trials, real‑world evidence studies/researches, and submission to regulatory agencies.

• Act as the lead trial statistician and provide expertise for assigned clinical trials, ensuring timely delivery of high‑quality, submission‑ready analyses.
• Collaborate with other functions including Clinical Development, Regulatory, Clinical Operations, Data Management, Statistical Programming, Medical Affairs, and Pharmacology.
• Provide statistical strategic inputs and planning to clinical development and other functions.
• Participate in the authoring, review, and implementation of study‑level statistical analysis plans, analysis dataset specifications, TFL shells, randomization approaches, analysis and reporting programs, and other analysis‑related deliverables.
• Perform and validate sample size and power calculations for all phases of clinical studies.
• Collaborate with data management to ensure accuracy, consistency, and completeness of trial data through ongoing review, cleaning, and reconciliation (e.g., SAE, labs, imaging, biomarkers, PRO/ePRO, etc.).
• Coordinate and oversee interim and final analyses, manage data release, and plan the timing of database snapshots/locks.
• Participate in QC and finalization of documents, including study reports, regulatory documents, abstracts, posters, manuscripts, publications, and press releases, to ensure data and analysis integrity.
• Provide statistical support for Medical Affairs and Outcomes Research functions regarding research publications and Real World Evidence (RWE) analyses.
• Provide statistical support for Data Monitoring Committee (DMC), DSUR/IB updates.
• Promote novel applications of existing statistical methods for study design and dossier submissions.
• Accountable for high‑quality data analysis and clinical trial result interpretation based on the study protocol.
• Proactively interact with agencies worldwide to resolve statistical issues associated with requests and submissions.
• Provide oversight, governance, and quality management of CRO analytic deliverables, holding vendors accountable to timelines, budget, and quality.
• Review and approve vendor specifications and resulting deliverables.
• Proactively identify and mitigate risks, implementing corrective actions to ensure successful partnerships and delivery.

• PhD or MS degree in Statistics, Biostatistics, Mathematics, or a related field.
• Minimum five (5) years’ experience in the biotech/pharmaceutical industry or CRO.
• Experience negotiating with regulatory authorities.
• Experience with clinical trial design/analysis, CDISC standards (SDTM, ADaM), and electronic data submission to regulatory agencies.
• Ability to calculate sample size and power for all phases of clinical studies.
• Proficiency in the use of statistical software (e.g., SAS, R, JMP).
• Prior experience in early‑phase clinical studies, PK/PD analyses.
• Broad knowledge and understanding of advanced statistical concepts and techniques; experience with modern data mining and AI technology preferred.
• Excellent interpersonal and communication skills, written and verbal.
• Ability to manage multiple projects and shifting priorities.
• Exceptional problem‑solving and analytical ability, with a focus on data integrity and risk management.

Annualized Salary Range (U.S.): $0.00 – $0.00

Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage, in accordance with the terms and conditions of the applicable plans.

• Employee Status:
  Regular
• Relocation:
  No relocation
• Visa Sponsorship:
  Not specified
• Travel Requirements:
  Must satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
• Hiring Position: 1 opening (Requisition : R538933)

Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.