Senior Manager, Statistical Programming at Axsome Therapeutics Inc

Warren, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, PharmaceuticalIndustries

Requirements

Master’s degree in a quantitative science discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 5 years of experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO or related environment
Demonstrated and applied SAS programming skills (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) and a good understanding of database systems
Working knowledge of R
Clinical Data Interchange Standards Consortium (CDISC) experience
Knowledge of clinical data analysis and reporting process as it relates to drug development
Excellent verbal and written communication skills
Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Experience working with CROs (preferred)

Responsibilities

Leads the statistical programming activities for assigned clinical development studies and programs
Ensures timely statistical analyses of clinical data per protocols and Statistical Analysis Plans; either directly or through CRO oversight 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
Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Action Plans, TLGs and TLG shells
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
May develop SOPs and training guidelines related to statistical programming
Performs other tasks and assignments as needed and specified by management
Participates in the development of new and review of existing statistical programming standard operating procedures and processes and biostatistics computing systems implementations and application development as appropriate
Supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate

Skills

Statistical Programming

Clinical Data Analysis

Statistical Analysis Plans

CRO Oversight

Biostatistics

SOPs

Programming Outputs

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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