Senior Director Biostatistics
Senior Director Biostatistics
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Salary Not Disclosed
1 Vacancy
Job Description
Position Summary:
As the Senior Director of Biostatistics you will lead and develop the statistical team within the assigned disease area ensuring statistical strategies align with clinical development objectives and regulatory standards. In this leadership role you will oversee the development execution and interpretation of statistical analyses maintaining data quality analysis integrity and compliance with regulatory requirements. Additionally you will champion innovative trial designs and methodologies while fostering a collaborative highperforming team culture. Reporting to the VP Head of Biometrics you will play a pivotal role in shaping clinical development strategy and achieving company goals.
Key Responsibilities:
Build mentor and lead a highperforming statistical team fostering collaboration learning and accountability.
Provide strategic and statistical leadership as a core member of the clinical development team collaborating with crossfunctional stakeholders.
Partner with medical regulatory pharmacology clinical operations and other functions to implement appropriate statistical methodologies and analysis plans.
Champion innovative statistical approaches such as adaptive seamless and Bayesian designs to enhance trial efficiency and success rates.
Ensure the accuracy integrity and consistency of statistical analyses across clinical development programs from Phase I through regulatory submissions and postapproval activities.
Contribute to the development and implementation of Standard Operating Procedures (SOPs) and workflows ensuring regulatory compliance and adherence to industry best practices.
Oversee CRO activities ensuring highquality deliverables adherence to timelines and efficient use of resources.
Requirements
Requirements:
Ph.D. in Biostatistics or Statistics with 10 years of industry experience or Master s degree with 12 years of experience.
Proven expertise in statistical activities for clinical development programs including successful regulatory submissions (NDAs BLAs or equivalent).
Demonstrated leadership in applying innovative statistical methodologies to enhance clinical trial efficiency.
Handson experience with statistical software such as SAS R or Python and familiarity with CDISC standards.
Strong problemsolving and strategic thinking skills with the ability to convey complex statistical concepts to diverse audiences.
Excellent communication and interpersonal skills to influence decisions and foster crossfunctional collaboration.
Preferred background in cardiometabolic diseases or related therapeutic areas.
Experience managing and mentoring teams is preferred.
Employment Type
Full Time
