Job Description:

As a Senior Principal Statistician, Biometrics you will be part of clinical development teams, contributing to the design, execution, analysis, and reporting of development programs. You will support both traditional clinical trial activities and broader evidence generation efforts, integrating clinical and real-world data to inform development and regulatory decision-making.

Responsibilities:

Evidence generation and real-world evidence (RWE)

• Supporting the design, conduct, analysis and reporting of RWE studies
• Contribute to integrated evidence generation strategies combining clinical trial and real-world data
• Supporting use of RWE in regulatory submissions, health technology assessment (HTA), and lifecycle planning

Clinical development and statistical contribution

• Providing statistical input to clinical development plans and target product profiles
• Authoring statistical analysis plans and contributing to study design
• Supporting analysis and interpretation of clinical trial data
• Contributing to clinical study reports and regulatory submissions

Assessment of business development opportunities

• Critically review and evaluate clinical trial data to assess efficacy, safety, and asset value, including opportunities for life cycle management such as label expansion, new indications, and geographic growth.
• Conduct gap analyses to identify missing data or limitations that may affect regulatory approval or market success and support the design of additional studies or registries to address these needs.
• Provide statistical input and perform independent analyses of key endpoints, subgroups, and sensitivity results to validate asset potential and strengthen evidence generation strategies by integrating clinical trial and real-world data.
• Contribute to due diligence reports, advise on statistical rigor, and evaluate the asset's readiness for regulatory submission, including review of analysis plans and submission documentation to inform business and scientific decisions.

Requirements:

• Bachelor's degree required, Master's degree or PhD in Statistics, Biostatistics, or a related quantitative field preferred
• 5+ years of experience working in the pharmaceutical industry•
• Proficiency in statistical programming languages (e.g., R, SAS)•
• Experience working with registry/claims data, including assessing the suitability and quality of such data sources in accordance with FDA guidance, and applying methodologies for analyzing observational data, e.g. constructing synthetic/external control arms, implementing the target trial emulation framework, or applying causal inference methods.•
• Strong analytical thinking and ability to translate complex data into clear insights•
• Effective communication skills, collaborative mindset and the ability to work in a dynamic environment

Ferring + you

At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our "People First" philosophy.

Our Compensation and Benefits

At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $191,000 to $225,000, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.

Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 15 paid holidays per year. We are proud to offer paid parental leave subject to a minimum period of employment at Ferring.

Location:
Parsippany, New Jersey