Senior Manager, Biostatistics

2 months ago

Princeton Junction, United States Sun Pharmaceutical Industries, Inc. Full time

Senior Manager, Biostatistics



This position reports to the local area Lead within Biostatistics and Data Management (BDM) group at SPARC. The main responsibilities will include hands on day to day support of one or more clinical studies. The position will provide oversight of all statistical activities during lifecycle of the study. The main activities would include review of the Protocols, eCRF, SDTM/ADAM specs review, SAP authoring, DB lock support topline results validation/interpretation, CSR co-authoring and eventual regulatory strategy development and submission. This is a hands-on position, requiring deep knowledge of statistical methods, willingness to learn new approaches, and ability to implement new statistical approaches in clinical research.

Responsibilities:

Serve as the statistical lead on one or more clinical studies in different phases of development
Engage in planning, methodology, and analysis for Phase 1-3 clinical studies, not limited to protocol development, sample size calculation, authoring of statistical analysis plans, data review, analysis implementation and interpretation
Review of case report forms (CRFs), data management plans, data specifications and clinical study reports, creation of randomization schedules, provide statistical analysis and reports to Data Monitoring Committees (DMCs)
Work with internal staff and/or vendors to assure that all programming and statistical analyses are completed
Provide statistical/programming support for responses to regulatory authorities related to submission reviews
Statistical programming/analyses including transfer, creation, conversion, and formatting of SAS data
Serve as the statistical representative on cross-functional teams
Participate in the development and maintenance of SOPs

Qualifications

PhD in statistics, biostatistics, or related field with 3+ years of clinical development experience; or an MS in statistics, biostatistics, or related field with 5+ years of clinical development experience
Demonstrated understanding of the drug development process
Demonstrated expertise with clinical trial design, study implementation, statistical methodology
Expert in SAS programming with demonstrated experience using Base SAS, SAS Stat, macros, analyses and reports
Strong knowledge and experience with sample size software like PASS, NQUERY etc.
Strong communication (oral and written), presentation, and analytical skills
Ability to work independently, prioritize tasks efficiently, and meet expected timelines
Ability to interact collaboratively with colleagues, investigators, key opinion leaders, and regulators.

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