Precision Medicine Group
Principal Biostatistician/Senior Principal Biostatistician
Remote, United States · Principal
Sponsorship not specified$147k-$243kDetected 1 day ago
Data StructuresStatisticsFDA RegulatorySASExperimental DesignLeadershipCommunicationProblem SolvingTime ManagementMentoringPublic SpeakingBiostatistics
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37Unrated
Cap-exempt (no lottery)0
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Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
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About the role
- Essential functions of the job include but are not limited to:
- Provide and/or verify sample size calculations
- Review statistical analysis plans written by other biostatisticians
Responsibilities
- Consult with clients regarding clinical trial study design and regulatory strategy
- Develop and review statistical methods of clinical study protocols
- Author statistical analysis plans of complex study design
- Serve as a Subject Matter Expert (SME) and develop/review procedural documents and work on new initiatives
- Ability to establish and teach others to maintain effective working relationships with coworkers, managers, and clients
Requirements
- Minimum Required:
- Senior Principal Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or related field with 12+ years of experience
- PhD degree in Statistics, Biostatistics, or related field with 9+ years of experience
- Principal Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience
- PhD degree in Statistics, Biostatistics, or related field with 7+ years experience
- Broad experience with regulatory submissions
- Sound knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
- Experience with SAS
- Experience with oncology and rare diseases
- Experience with DMCs
- Extensive experience consulting with clients regarding clinical trial study design and regulatory strategy
- Superior understanding of a statistical methodology (e.g., Bayesian adaptive study design, Survival analysis, Repeated measures)
Compensation
- Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.
Benefits
- Service oriented, accountable, and flexible
Company info
- Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process.
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