Senior Manager - Biostatistics (Remote)

A biotech company is actively seeking a new Senior Manager, Biostatistics for a great Remote opportunity with their staff.

Responsibilities :

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

Work collaboratively within the 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

Qualifications :

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 a 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 guidelines, FDA / EMA / other regulatory authority guidance

Solid understanding of Mathematical and Statistical principles

Detailed-oriented with organization, problem solving and prioritization skills

Desired Skills :

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

by Jobble