[Hiring] Associate Director, Biostatistics @Definium Therapeutics

Role Description

As an Associate Director, Biostatistics, this person will provide statistical support for pipeline compounds’ clinical development, regulatory filing, and commercialization. Reporting to the Vice President, Head of Biometrics and Data Science, the successful candidate will serve as the biostatistician for assigned clinical trials to provide statistical leadership from trial design, data analysis, to results interpretation and dissemination. This role will also provide statistical support to regulatory filing dossier preparation. As a hands-on biostatistician, this individual will be responsible for all statistical deliverables for the assigned projects in collaboration with members of the Biometrics team and in multi-functional project teams. Working closely with the Definium Statistical Programming group, this individual will oversee the deliverables from statistical vendors to ensure high quality and meeting timeline. Additionally, the responsibilities of this individual include performing statistical analyses on trial data using SAS programs and partnering with the Clinical Data Management group to support data cleaning activities.

• Serve as Study Biostatistician for assigned clinical trials to provide statistical support from design, analysis to reporting.
• Conduct integrated data analyses to support regulatory filing dossier preparation.
• Collaborate with cross-functional experts on clinical trial designs and contribute to determination of objectives, endpoints, and sample size.
• Author statistical methods section in the protocol and review the protocol throughout.
• Ensure the accuracy of randomization algorithm and contribute to eCRF design to align study objectives, data analysis, and data collection.
• Work with statistical vendors and internal Statistical Programming team to deliver study results or integrated analyses with quality and speed.
• Provide statistical input to any form of data reporting or external dissemination, including clinical study report, regulatory communication, and publication.
• Conduct data analyses as needed using own SAS programs in collaboration with internal Statistical Programming team.

Qualifications

• A PhD degree in Statistics, Biostatistics or relevant fields with at least 7 years’ working experience, or a Master’s degree in Statistics, Biostatistics or relevant fields with at least 10 years’ working experience, in pharmaceutical or biotechnology companies.
• Solid statistical knowledge and experience in clinical trial design (early to late phase), data analysis, and reporting.
• Rich experience in authoring study SAP and TFL shells and driving the review process to achieve consensus among review functions to deliver the final versions.
• Extensive experience in managing statistical vendors to implement SAP and deliver study results with quality and speed.
• Solid knowledge and extensive experience of using statistical computational languages, such as SAS, to perform data analysis.
• Working knowledge of regulatory guidance relevant to clinical trials from design to analysis.
• Demonstrated capacity for collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Data Science, and other relevant functions to deliver common goals.
• Strong organizational and project management skills; demonstrated interest in continued learning and growing.
• Detail-oriented and hold high standards of excellence for their work products.
• Deliver and communicate effectively in the work-from-home environment.
• Excellent interpersonal skills and is a good team player.

Requirements

• Experience in CNS drug development from clinical trials design to data analysis.
• Experience in regulatory filing from integrated data analysis planning and execution to submission dossier preparation.

Benefits

• 100% paid health benefits including Medical, Dental, and Vision for you and your dependents.
• 401(k) program with company match and vesting after the turn of the first month after your start date.
• Flexible time off.
• Generous parental leave and some fun fringe perks!