Senior Biostatistician

Job Description

Job Title: Senior Biostatistician

Pay Range: $90 to $104/hr on W2

Location : Remote

Duration : 12+ Months

Job Requirements:

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• Education: Master’s in Statistics/Biostatistics required.
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• Experience: 4+ years in Biotech/Pharma or related industry.
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• Core: Hands-on clinical trial design, analysis & reporting , especially Randomized Controlled Trials (RCTs) .
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• Programming: SAS – REQUIRED ; R is a plus.
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• Data Standards: Strong hands-on CDISC, SDTM & ADaM experience.
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• Experience supporting clinical development programs across phases; regulatory submission/support experience preferred.
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• Experience working with statistical programmers, cross-functional teams, CROs/vendors .
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• Ability to explain complex statistical concepts to non-statistical stakeholders .
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• Quality/Operations: Pharma SOP, QC, and statistical deliverable experience.
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• Nice-to-Have: Pain/acute or chronic pain indication, RWE/observational studies/causal inference , and regulatory interactions.
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Duties:

The role is responsible for conducting biostatistical activities to support all phases of clinical development and post-marketing efforts. This role will collaborate closely with other biostatisticians, statistical programmers, and cross-functional team members, as well as with contract research organization (CRO) partners and other vendors to meet company R&D objectives. Individuals in this role will support the development and review of statistical deliverables and provide high-quality analytical outputs to inform clinical and regulatory decision-making.

Knowledge, Skills, and Abilities:

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• Strong understanding of clinical trial design principles, including adaptive designs.
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• Ability to effectively communicate complex statistical analyses and concepts to non-statisticians in non-technical language.
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• Ability to balance scientific rigor with operational and business considerations in a fast-paced development environment.
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• Knowledge and extensive hands-on experience with CDISC methodologies and industry data standards including SDTM and ADAM.
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• Demonstrated ability to manage multiple priorities and timelines while delivering high-quality outputs.
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• Working knowledge of regulatory guidelines and expectations in pharmaceutical development; experience supporting regulatory interactions is a plus.
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• Programming experience in SAS is required; experience in R is a plus.
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• Familiarity with real-world evidence and observational research methodologies (e.g., causal inference) is a plus.
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• Prior experience supporting clinical development programs in acute or chronic pain indications is a plus.
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• Understanding of standard operating procedures, process and quality control associated with biostatistics in the pharmaceutical industry.
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Education and Experience:

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• Master’s Degree in statistics, biostatistics from accredited college or university
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• Minimum 4 years of experience within the biotech/pharmaceuticals industry or a related field.
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• Experience in statistical responsibilities for design, analysis, and reporting of randomized controlled trials.
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