Senior Director, Biostatistics

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and provide strategic direction for assigned clinical development programs.

• Oversee statistical activities related to clinical trials, which includes aiding in trial designs, drafting statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting clinical trial data analyses.

• Collaborate with both internal and external cross-functional study teams.

• Facilitate interactions with global Health Authorities.

• Execute ad-hoc analyses and oversee biometrics vendors in the preparation of analysis files, conducting statistical analyses, and delivering analytical results and data files.

⛳️ Requirements

• PhD in Biostatistics, Statistics, or a related discipline with a minimum of 10-12 years of experience in biostatistics within the pharmaceutical, biotech, or CRO sectors.

• In-depth understanding of statistical methodologies and their application in clinical trials and health research, with a preference for familiarity with Bayesian methods.

• Experience in regulatory submissions and engagement with regulatory bodies.

• Proficient in statistical software (e.g., SAS, R) and data management systems.

• Knowledgeable in CDSIC standards, including SDTM, ADaM, and CDASH.

• Proven ability to work independently within a matrixed organization and to address emerging challenges effectively.

• Exceptional communication and interpersonal skills, complemented by strong organizational abilities.

• Capacity to collaborate effectively within a multidisciplinary team environment.

🏝️ Benefits

• Engage in a fast-paced, dynamic environment where you can influence the culture of our emerging company, contribute significantly to the advancement of impactful medicines, and accelerate your learning.

• Competitive salary and benefits package, encompassing base salary, performance bonuses, equity grant opportunities, and health, welfare, and retirement benefits.

• Unlimited paid time off (PTO).

• Two company-wide shutdowns each year, lasting one week each.

• Commitment to offering professional development opportunities.

• Flexible remote working environment with regular in-person meetings to tackle complex challenges and foster relationships.