Manager, Statistics

Job Description
Key Responsibilities
 
Responsible for the design, analysis & reporting of clinical trials or other scientific research studies.
Apply statistical techniques to facilitate better decision-making & improve business operation.
Regularly interact with management of different levels in strategy meetings.
Contribute to strategic planning to ensure statistically optimized non-clinical development plans and assist in the creation of strategic objectives for regulatory filings.
Participate in the planning/design, conduct, analysis, and interpretation of non-clinical studies & regulatory submissions.
Collaborate with colleagues from other departments to ensure compliance with regulations & help implement regulatory initiatives such as Quality by Design & process validation.
Participate in establishing departmental and non-clinical SOPs & guidelines.
Develop statistical tools to streamline process development, QC testing & troubleshooting.
Prepare statistical courses & provide training for scientists. Develop & deliver statistical & scientific publications & present internally & externally.
Collaborate with other statisticians in improving & sharing statistical approaches.
Develop protocols & statistical analysis plans or product safety analysis plans, integrated summary of safety analysis plans, & analysis plans for GMA evidence generation with details for programming implementation.
Implement statistical methodology in scientific investigations & identify scientifically appropriate data collection instruments.
Identify & report data issues or violations of study assumptions & provide programming specifications for derived variables & analysis datasets.
Identify & anticipate issues arising in the study design, conduct & propose scientifically sound approaches.
Evaluate appropriateness of available software for planned analyses & assess needs for potential development of novel statistical methodology.
Ensure accuracy & internal consistency of reports & publications, including tables, listings, & figures utilizing statistical software such as SAS & R.
Ensure that study results & conclusions are scientifically sound, clearly presented, & consistent with statistical analyses provided.
Provide responses to questions, & pursue analyses suggested by data.
Collaborate with cross functional team for benefit-risk planning & assessment.
Contribute to cross-functional development of output specifications to address both pre-planned safety analyses & ad hoc requests.
Collaborate/lead within the Safety Statistics Group to implement strategic initiatives that address processes related to interpreting, monitoring, assessing, & reporting safety data to characterize the safety profile of organizational products, improve efficiencies, & provide consistency across therapeutic areas.