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Senior Manager, Biostatistics

Boston, MA 02108

Posted: 02/16/2024 Category: Pharmaceutical Job Number: 282934-8_1 Salary: $175,000 - $185,000

Job Description

Smith Hanley Associates
Senior Manager, Biostatistics
Remote
$175k - $185k Base Salary
Nihar Parikh [email protected]

Responsibilities:
You will be responsible for the statistical science aspects of clinical studies and projects.
You will lead and manage all statistical activities within clinical studies and projects, including study design and sample size estimation.
Provide statistical review and interpretation of pre-clinical data and clinical data from studies.
Develop and maintain study documents with regard to statistical aspects of the studies, including SAPs.
Provide input to study documents, study protocol, data management plan, operational documents, clinical study report, and author relevant sections of study documents.
Manage contractors/vendors to oversee quality of work to ensure they meet an agreed study plan.
Ensure data meets the required standards for regulatory submission to applicable agencies.
Review data to ensure compliance with CDISC standards.
Act as an advisor to clinical/research scientists engaged in the scientific aspects of clinical development studies/projects and provide statistical programming support as needed.

Requirements:
This position requires a Ph.D. or a Masters degree in Statistics, Mathematics, Biometrics or Medical Statistics or a related discipline.
5+ years of statistics experience within the pharmaceutical industry, including clinical trial design, analysis and reporting.
Experience in Phase III pivotal clinical development studies, with submission of marketing applications to regulatory agencies is required.
Demonstrated expertise in the application of statistical methods in drug/device development for the treatment of disease, along with knowledge of health authority standards of statistical analytics.
Must possess experience in analysis and interpretation of study results, and authoring of study reports that are accurate and reproducible.
Possesses knowledge and pharmaceutical experience in the creation of clinical development strategic planning and the design and implementation of clinical studies.
Experience with NDA submission to regulatory agencies
Successful track record of managing CROs conducting statistical aspects of clinical trials.
Understanding of and compliance with the principles of GCP guidelines and global regulatory requirements.
Demonstrated knowledge of and experience with FDA regulations and guidelines, in particular statistical analysis and CDISC standards.
Proven experience in all aspects of clinical trial execution with the ability to follow SOPs and accepted practices.
Requires strong statistical programming skills in SAS.

www.smithhanley.com

Meet Your Recruiter

Nihar Parikh
Executive Recruiter

Nihar specializes in the clinical domain and works across biostatistics, clinical trials/research, data management, health economics/RWE, medical affairs, statistical programming, and other R&D areas within pharma and biotech. He has more than ten years of recruiting experience and attributes his success to the ability to build good relationships, listen attentively, be proactive, continuously self-improve, and show empathy. Nihar plans to carry Smith Hanley’s stellar reputation in the pharma business for many years to come. Outside of work, Nihar likes to spend his time following Chicago sports, travel, podcasts, yoga, golf, and investing. 

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