Job Details

We are hiring a Senior Manager, Biostatistics on a full-time contract basis.

This position is remote based.

Responsibilities include, but are not limited to:

· Contribute to study level tasks from statistics perspective, including study design and sample size determination; Author/review statistics section in the protocol, SAP and DMC charter; Create/review study randomization files; Develop TFL shell and specification Review CRFs and other study documentations; Active participation in study related meetings

· Work collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting

· Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements

· Independently conduct analyses suggested by the data; Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results

· Contribute to developing standards and research in advanced statistical methodologies

· Author/review regulatory documents or scientific publications

Requirements:

· PhD in Statistics or Biostatistics with a minimum of 5 years (min 8 years for Master's degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry

· Experienced in NDA / BLA / MAA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction

· Experienced as study lead statistician and contributing to strategy discussion in cross functional settings

· Experienced in study level work including authoring SAP and TFL specification

· Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance

· Solid understanding of mathematical and statistical principles

· Detailed-oriented with organization, problem solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according to company timeline

· Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies