Principal Scientist, Biostatistics, Clinical Safety Statistics

Job Description

Statisticians in the Clinical Safety Statistics (CSS) group strategize plan and analyze safety data from clinical trials and post-marketing sources for drug and vaccine development programs to help inform the safety profile and benefit-risk understanding of products throughout their life cycle.

Key Responsibilities for this Position:

• Serve as the CSS therapeutic area lead for the vaccine and infectious disease (VID) projects.

• Provide statistical leadership and support to the Risk Management and Safety Teams (RMSTs) in the strategic planning and execution of compound level safety evaluation across product life cycle in vaccine and drug programs

• Design develop and implement innovative statistical methods and tools for safety evaluation.

Primary Activities:

• Provide statistical leadership for compound safety evaluation strategy and analysis in vaccines and infectious diseases; support CSS projects in other therapeutic areas as needed.

• Partner with Clinical Safety Risk Management Early/Late Development Statistics Epidemiology Programming and other RMST functions to plan and execute on aggregate safety evaluation in vaccine and drug projects

• Ensure safety deliverables meet analysis requirements relevant SOPs and regulatory guidance.

• Communicate safety-analysis results and recommendations to teams management regulators and investigators.

• Develop processes job aids statistical methods and tools for safety evaluation that address scientific and business needs

Education:

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years relevant work experience or masters with a minimum of 9 years relevant work experience.

Required:

• Solid knowledge of statistical analysis methodologies. Solid experience ofusing statistical software (eg SAS or R).

• Solid knowledge of regulatory requirements regarding the analysis and reporting of safety data.

• Strong project management and leadership skills including the ability to influence cross-functional teams and align priorities at the Therapeutic Area level.

• Knowledge of and experience with clinical trial design and analysis. Experience with the analysis and interpretation of integrated safety data

• Knowledge of statistical methods appropriate for the analysis of clinical trial data in both randomized and non-randomized studies

Preferred:

• Solid Knowledge of drug/vaccine development process from discovery preclinical research clinical trials (Phase 1 2 and 3) NDA review to post-marketing evaluation

• Knowledge and experience in developing/applying AI toolsin drug and vaccine development projects.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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