Director, Biostatistics

Definium Therapeutics

5d • $224,643 - $249,312 • Remote

About The Position

Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing accessible treatments for psychiatric and neurological disorders using psychedelics. Our lead candidate targets anxiety, depression, and PTSD, while another targets autism spectrum disorder. We are dedicated to advancing a new generation of therapeutics to address the underlying causes of these conditions and improve mental healthcare. Headquartered in New York, Definium Therapeutics is publicly traded on Nasdaq.

Requirements

• PhD degree in Statistics or Biostatistics.
• At least 10 years of working experience in pharmaceutical or biotechnology companies.
• Solid statistical knowledge and experience in clinical trial design (early to late phase), data analysis, and reporting.
• Strong track record using statistical methods to solve real problems in clinical trials, leading to sound decision-making and/or compound advancement.
• Rich experience in authoring study SAP and TFL shells and driving the review process to achieve consensus.
• 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.
• Strong organizational and project management skills.
• Demonstrated interest in continued learning and growing.
• Detail-oriented with high standards of excellence for own work products.
• Ability to deliver and communicate effectively in a work-from-home environment.
• Excellent interpersonal skills and ability to be a good team player.

Responsibilities

• Provide statistical support for clinical development of pipeline compounds, regulatory filing, and commercialization efforts.
• Serve as the lead biostatistician for assigned clinical programs and/or studies, providing statistical leadership from trial design to data analysis, interpretation, and dissemination.
• Be hands-on while offering statistical and strategic input to all relevant clinical activities.
• Ensure high quality and timely deliverables from statistical vendors, in collaboration with the Statistical Programming group and multi-functional teams.
• Perform statistical analyses using SAS programs as needed and support data cleaning activities.
• Provide statistical input to the creation of clinical development plans.
• Collaborate with cross-functional experts on clinical trial designs, including determination of objectives, endpoints, and sample size.
• Author statistical methods sections and review protocols.
• Ensure accuracy of randomization algorithms and contribute to eCRF design.
• Be the primary owner of study statistical analysis plans (SAP) and table/figure/listing (TFL) shells.
• Manage statistical vendors to implement SAP and deliver study results.
• Manage statistical vendors for other data analyses (e.g., DMC support, interim analysis).
• Provide statistical input to data reporting and external dissemination (clinical study reports, regulatory communications, publications).
• Conduct data analyses using SAS programs in collaboration with the Statistical Program group for validation.
• Contribute to the development of Biometrics’ SOPs.

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
• Some fun fringe perks!

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree