Centessa
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation.
Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.
Description of Role
The Director/Associate Director in Biostatistics will provide statistical leadership in one or more therapeutic areas, oversight of clinical development planning and execution for multiple indications at Centessa.
Key Responsibilities
Lead biostatistics efforts in a team setting and focus on business priorities
Collaborate on clinical development plan for one or more molecules to provide biostatistical perspective and insight
Determine innovative study designs, appropriate statistical tests and methods for evaluating and generating statistical hypotheses to meet study and regulatory requirements
At study level, author and review statistical sections for protocols, statistical power and sample size estimate, randomization schemes, clinical study reports, and regulatory submission documents
Lead the planning, organization and analysis of different data sources to enable delivery of the statistical analysis plan and clinical study endpoints for assigned products
Work with cross-functional team to develop ad hoc analysis plans and ensure analyses are performed appropriately by programming staff
Lead and guide third-party statistical vendors and contractors in the execution of relevant deliverables (eg, TLFs, SAPs, blinding plans)
Oversee preparation, conduct, and execution for Data Monitoring Committee meetings
Maintain expertise in state-of-the-art statistical methodologies and statistical analyses
Collaborate with Data Management to ensure data integrity and quality
Qualifications
MSc (PhD preferred) in Statistics, Biostatistics, or related field
Minimum of 6 years' experience applying statistical methods in the pharmaceutical industry, with early (Phase 1 and Phase 2) and late (registrational) trial experience highly desired
Knowledge and experience in neurology and/or oncology therapeutic areas preferred
Ability to work in a cross-functional matrix environment, and proactively influence teams with innovative clinical development strategy
Experience of interacting with regulatory agencies, including FDA and EMA, highly desirable
Demonstrates strong communication skills, both oral and written
Ability to use SAS and/or R programming languages to perform analyses, conduct statistical modeling, and validate important data derivations
Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets
Demonstrates breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes, and create business impact
Work Location
The Director/Sr. Director in Biostatistics is a remote role based in the US, with infrequent (
POSITION: Full-Time, Exempt EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. For further information on how Centessa processes your personal data in relation to recruitment activities, read our Candidate Privacy Notice.
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POSITION: Full-Time, Exempt EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. For further information on how Centessa processes your personal data in relation to recruitment activities, read our Candidate Privacy Notice.
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