Senior Scientist, Biostatistics

Job Description

The Position

Reporting to Executive Director, Biostatistics under Clinical Data Sciences (CDS), the Senior Scientist, Biostatistics is responsible for leading the statistical activities of 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.

Responsibilities

• 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 but not limited to Clinical Development, Regulatory, Clinical Operations, Data Management, Statistical Programming, Medical Affairs, and Pharmacologists.

• Provide statistical strategic inputs/planning to clinical development and other functions.

• Participate in the authoring, review, and implementation of study-level statistical analysis plans, analysis dataset specifications and TFL shells, randomization approaches, analysis and reporting programs, and other analysis-related deliverables and activities.

• Perform and validate sample size and power calculation 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 (SAE, labs, imaging, biomarkers, PRO/ePRO, etc.).

• Coordinate and oversee interim and final analyses, manage data release, plan the timing of database snapshots/locks. Participate in QC and finalization of various documents, including study reports, regulatory documents abstracts, posters, manuscripts, publications, press releases, etc. to ensure data and analysis integrity.

• Provide statistical support for the Medical Affair and Outcome Research functions regarding research publications and Real World Evidence (RWE) analyses.

• Provide statistical support for DMC, DSUR/IB update.

• Promote the novel application of existing statistics 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 escalate risks, implementing corrective actions to ensure successful partnership and delivery.

Required Education, Experience and Skills

• PhD or MS degree in Statistics, Biostatistics, Mathematics, or a related field.

• Minimum five (five) years of experience in biotech/pharmaceutical industry or CRO.

• Experience with negotiation with regulatory authorities.

• Experience with clinical trial design/analysis, CDISC standards (SDTM, ADaM), and associated 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 (eg: SAS, R, JMP, etc.).

• Prior experience on 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 is preferred.

• Excellent interpersonal and communication skills both 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.

Secondary Language(s) Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

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