Senior Biostatistician

Integrated Resources, Inc ( IRI ); United States; On-site; USD 110,000 - 160,000; Full time

Job summary

Integrated Resources, Inc (IRI) is seeking a Senior Biostatistician to lead biostatistical activities across all phases of clinical development. The role involves collaboration with statisticians, programmers, CROs, and cross‑functional teams to deliver high‑quality statistical outputs for regulatory decision‑making.

Requires a Master’s in statistics/biostatistics and at least 4 years in biotech/pharma, with strong SAS skills and CDISC data standards experience.

Qualifications

• Master’s degree in statistics or biostatistics.
• 4+ years in Biotech/Pharma or related industry.
• Experience with randomized controlled trials design, analysis and reporting.
• Proficiency in SAS is required; R is a plus.
• Strong knowledge of CDISC, SDTM and ADaM data standards.
• Experience supporting regulatory submissions is a plus.
• Ability to communicate statistical concepts to non-statisticians.

Responsibilities

• Conduct biostatistical activities across all phases of clinical development and post‑marketing efforts.
• Collaborate with biostatisticians, statistical programmers, and cross‑functional teams, as well as CROs/vendors.
• Develop and review statistical deliverables to inform clinical and regulatory decision‑making.

Skills

Clinical trial design

RCTs (Randomized Controlled Trials)

SAS programming

R programming

CDISC SDTM ADaM

Statistical analysis & reporting

Communication to non-statisticians

Regulatory submission support

Education

Master’s degree in statistics/biostatistics

Tools

SAS

R

Job description

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

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:

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

Education and Experience:

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