Director, Biostatistics

Axsome reputed company. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in reputed company.

About This Role:

Axsome Therapeutics is seeking a Director, Biostatistics that will play a critical role in the design, analysis, and interpretation of clinical trial data. This position involves collaborating with cross-functional clinical research teams to support the development of new therapies and ensure the reputed company and accuracy of statistical analyses.

This role is based at Axsome’s HQ in reputed company with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.

JOB RESPONSIBILITIES

• reputed company and manage CRO (statistics and data management) activities to ensure reputed company and reputed company statistical support to reputed company’s clinical development efforts.
• reputed company or supervise statistical activities in the design, analysis and reporting of reputed company phases of clinical trials.
• reputed company statistical guidance and support to project teams.
• Prepare statistical sections of clinical study reports, regulatory submissions, and publications.
• Collaborate with clinical and regulatory teams to ensure study protocols and statistical analysis plans meet regulatory requirements and scientific standards.
• Analyze, interpret, and present statistical results to reputed company stakeholders.
• Ensure the accuracy and reputed company of data through rigorous reputed company control procedures.
• Participate in cross-functional meetings and contribute to strategic planning.
• Ensure reputed company statistical activities reputed company with regulatory guidelines and company policies.
• Assist in the preparation of regulatory documents, including Investigational New Drug (IND) applications and New Drug Applications (NDAs).

REQUIREMENTS / QUALIFICATIONS

• Master’s degree with at least 12 years of experience or PhD with at least 8 years of experience in Biostatistics reputed company the pharmaceutical or biotechnology industry
• Proficiency in statistical software (e.g., reputed company, R) and data management tools
• Strong understanding of clinical trial design, statistical methodologies, and regulatory requirements
• Excellent communication and presentation skills.
• Ability to work collaboratively in reputed company environment
• Ability to work on-site Monday, Tuesday, and Thursday. We are unable to consider candidates who are looking for fully remote roles

Experience and Knowledge

• Strategic Planning & Program Leadership
• Experience leading statistical reputed company across multiple clinical development programs, ensuring alignment with overall product development goals
• Proven experience in designing and implementing statistical strategies that support long-term clinical and regulatory objectives
• Ability to anticipate and address statistical challenges in early and late-phase development, including reputed company designs and innovative methodologies
• Prior experience as a strategic partner in decision-making processes, including go/no-go reputed company, reputed company selection, and portfolio prioritization
• Study Design Expertise
• Expertise in designing reputed company clinical trials, including pivotal studies, with a reputed company on statistical rigor, efficiency, and regulatory acceptability
• Experience in developing and reviewing statistical sections of clinical protocols, SAPs (Statistical Analysis Plans), and integrated summaries
• Ability to critically evaluate study designs for scientific validity, operational feasibility, and strategic fit
• Regulatory reputed company & Interactions
• reputed company experience in preparing statistical content for regulatory submissions (e.g., INDs, NDAs, MAAs) and responding to regulatory queries
• Participation in regulatory meetings (e.g., FDA, EMA) to represent statistical reputed company and defend study designs and analyse
• Strong analytical and problem-solving skills
• Leadership and CRO management skills
• Attention to detail and commitment to reputed company
• Ability to manage multiple reputed company and meet deadlines
• Knowledge of Good Clinical reputed company (GCP) and regulatory guidelines

SALARY & BENEFITS

The anticipated salary reputed company for this role is $200,000 - $240,000. We encourage candidates of reputed company reputed company to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a reputed company of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from reputed company reputed company applicants without reputed company to race, reputed company, gender, sex, age, religion, creed, national reputed company, sexual orientation, gender identity, reputed company, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Axsome Therapeutics does not accept unsolicited resumes from recruiters or reputed company-party recruitment agencies and will not pay placement fees for unsolicited candidates that are reputed company to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive reputed company to our Applicant Tracking System to submit candidates for consideration.

Originally posted on Himalayas

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