A pharmaceutical company in Massachusetts is actively seeking a new Senior Manager, Biostatistics to their team. Acting as statistical study lead, the Senior Manager Biostatistics will be responsible for providing technical input and biostatistical support on the design and conduct of clinical studies.
Responsibilities:
- Lead in study level tasks, ensuring statistical integrity; contribute strategically to the supporting projects from statistics perspective
- Contribute to study level tasks from statistics perspective, including study design and sample size determination, protocol statistics section, SAP and DMC charter
- Review study randomization files and develop TFL shell and specification
- Review CRFs and other study documentations
- Work collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
- 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
- Review regulatory documents or scientific publications
Qualifications:
- D, in Statistics or Biostatistics with a minimum of 3 years (min 6 years for Master's degree) of post-graduate experience in the Clinical Trials setting in the pharmaceutical industry
- Experience as or is capable to act as Study Lead Statistician and contribute to strategy discussion in cross functional settings
- Experience in study level work including authoring SAP and TFL specification
- Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance
- Familiar with SAS and R
- Solid understanding of Mathematical and Statistical principles
- Detailed-oriented with organization, problem solving and prioritization skills
Desired Skills:
- Experience in NDA / BLA / MAA activities as a contributor from statistics perspective and direct involvement in Regulatory interaction
- Knowledge in CDISC including SDTM, ADaM, and controlled terminologies
