Associate Director, Statistical Programming at Axsome Therapeutics Inc

Warren, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

Master’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) OR Bachelor’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science)
Minimum of 7 years of progressively responsible experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO or related environment (with Master’s degree) OR Minimum of 9 years of progressively responsible experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO or related environment (with Bachelor’s degree)
Statistical Programming
Clinical Development Programs
Statistical Analysis Plans
SOP Development
CRO Management & Interaction
Data Management/Analysis

Responsibilities

Leads the statistical programming project team (including Clinical Research Organization (CRO) oversight as necessary) in support of clinical development programs in the assigned therapeutic areas
Ensures timely statistical analyses of clinical data per protocols and Statistical Analysis Plans; develops statistical programs and produces programmed outputs used to create integrated scientific reports for clinical trial results
Participates in study team meetings as a representative of the Biostatistics function
Communicates statistical issues and acts as a statistical/programming resource to the development teams
Participates in the assessment, selection and evaluation of CROs
Interacts with CROs involved in data management/analysis activities to ensure that their statistical analyses and resulting outputs are accurate and consistent with the contractually agreed upon deliverables; works with vendor staff to characterize and resolve issues related to data analysis
Creates/Reviews derived dataset specifications and the related analysis datasets
Develops SOPs and training guidelines related to statistical programming
May manage, coach and mentor direct reports
Performs other tasks and assignments as needed and specified by management

Skills

Key technologies and capabilities for this role

Statistical ProgrammingStatistical Analysis PlansSOP DevelopmentCRO ManagementData ManagementStatistical AnalysisBiostatistics Computing

Questions & Answers

Common questions about this position

What is the salary for the Associate Director, Statistical Programming role?

This information is not specified in the job description.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What education and experience are required for this position?

A Master’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) or a Bachelor’s degree is required, along with a minimum of 7 years (Master’s) or 9 years (Bachelor’s) of progressively responsible experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO or related environment.

What key skills are needed for the Associate Director, Statistical Programming role?

Key skills include statistical programming, leading clinical development programs, oversight of CROs, SOP development, and data management/analysis.

What makes a strong candidate for this Associate Director role?

Strong candidates will have a degree in a quantitative field, extensive experience in statistical programming within pharma/biotech/CRO settings, and leadership skills in managing teams, CROs, and clinical data analyses.

Axsome Therapeutics Inc

Develops therapies for CNS disorders

About Axsome Therapeutics Inc

Axsome Therapeutics develops therapies for central nervous system (CNS) disorders, focusing on conditions like major depressive disorder, treatment-resistant depression, and Alzheimer's agitation. Their main product, AXS-05, is an oral medication that works by blocking NMDA receptors in the brain, which helps regulate mood. This drug has shown positive results in clinical trials and has received special FDA status to speed up its approval process. Unlike many competitors, Axsome emphasizes addressing unmet medical needs in CNS disorders and aims to improve patient outcomes through rigorous research and development. The company's goal is to bring effective treatments to market, enhancing the quality of life for patients suffering from these conditions.

New York City, New YorkHeadquarters

2012Year Founded

$430.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Performance Bonus

Company Equity

Risks

Increased competition from companies like Compass Pathways in the CNS market.

Potential delays in AXS-07 launch amid growing market anticipation.

Departure of key personnel like Lori Englebert may impact strategic direction.

Differentiation

Axsome focuses on CNS disorders with limited current treatment options.

AXS-05, an NMDA receptor antagonist, targets major depressive disorder and treatment-resistant depression.

Axsome's balanced portfolio includes both clinical and research stage products.

Upsides

FDA's fast-tracking of CNS treatments could expedite Axsome's drug approvals.

Increased investment in CNS R&D drives innovation, benefiting Axsome's pipeline.

Growing personalized medicine trend offers Axsome opportunities for tailored therapies.

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