A pharmaceutical company in California is actively seeking an experienced Biostatistician to join their growing team as a Senior Manager.

Responsibilities:
- Leading in study-level tasks, ensuring statistical integrity; contributing strategically to the supporting projects from a statistical perspective
- Contributing to study-level tasks from a statistics perspective, including study design and sample size determination, protocol statistics section, SAP, and DMC charter
- Reviewing study randomization files
- Developing TFL shell and specification
- Reviewing CRFs and other study documentation
- Working collaboratively within the Biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
- Independently conducting analyses suggested by the data
- Proposing new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results
- Contributing to developing standards and research in advanced statistical methodologies
- Reviewing regulatory documents or scientific publications
- Performing other duties, as needed
Qualifications:
- PhD in Statistics or Biostatistics with a minimum of 3 years (min 6 years for Master's Degree) of post-graduate experience in a Clinical Trials setting in the Pharmaceutical industry
- Experienced 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
- Familiar with ICH guidelines, FDA / EMA / other regulatory authority guidance
- Familiar with SAS and R
- Solid understanding of Mathematical and Statistical principles
- Detail-oriented with organization, problem-solving solving and prioritization skills
Desired Skills:
- Experience in NDA / BLA / MAA activities as a contributor from a Statistics perspective and direct involvement in regulatory interaction
- Knowledge in CDISC, including SDTM, ADaM, and controlled terminologies
