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
