Sr. Manager, Biostatistics Contractor

Greenkey Resources LLC; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Senior Manager in Biostatistics to lead statistical studies and provide crucial support in clinical trials. This role involves strategic contributions to study design and execution, ensuring statistical integrity and compliance with regulatory standards. The ideal candidate will have a PhD in Statistics or Biostatistics and significant experience in the pharmaceutical industry. Join a forward-thinking company that values innovation and collaboration, where your expertise in statistical methodologies will directly impact the success of clinical research projects.

Qualifications

• PhD in Statistics/Biostatistics with 3+ years in clinical trials.
• Experience in NDA/BLA/MAA activities preferred.

Responsibilities

• Lead study-level tasks ensuring statistical integrity.
• Collaborate with biometrics and cross-functional teams.

Skills

Statistical Analysis

Clinical Trials

Problem-Solving

Organizational Skills

Regulatory Guidelines Familiarity

Education

PhD in Statistics or Biostatistics

Master's Degree in Statistics or Biostatistics

Tools

SAS

R

Job description

Sr. Manager, Biostatistics Contractor

Job Description

The Senior Manager, Biostatistics acts as a statistical study lead; provides technical input and biostatistical support on the design and conduct of clinical studies; participates in the evaluation, interpretation, and reporting of study results; performs statistical analyses; and provides timely support to project teams on all statistical matters.

Responsibilities

1. Lead study-level tasks, ensuring statistical integrity; contribute strategically to supporting projects from a statistical perspective.
2. Contribute to study-level tasks, including study design, sample size determination, protocol statistics section, SAP, and DMC charter; review study randomization files; develop TFL shell and specifications; review CRFs and other study documents; actively participate in study-related meetings.
3. Work collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting.
4. Independently conduct analyses suggested by the data; propose new or novel statistical methodological approaches to improve the efficiency and sensitivity of study results.
5. Contribute to developing standards and research in advanced statistical methodologies.
6. Review regulatory documents or scientific publications.

Requirements

• PhD in Statistics or Biostatistics with a minimum of 3 years (or 6 years for Master's degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry.
• Experience in NDA/BLA/MAA activities from a statistical perspective and direct involvement in regulatory interactions are preferred.
• Experience as or capable of acting as a study lead statistician and contributing to strategy discussions in cross-functional settings.
• Experience in study-level work, including authoring SAP and TFL specifications.
• Familiarity with ICH guidelines, FDA, EMA, and other regulatory authority guidance.
• Solid understanding of mathematical and statistical principles.
• Detail-oriented with strong organizational, problem-solving, and prioritization skills; demonstrated ability to manage multiple tasks according to company timelines.
• Familiar with SAS and R; preferably with knowledge of CDISC standards, including SDTM, ADaM, and controlled terminologies.