MapLight Therapeutics

MapLight Therapeutics is a clinical-stage biotech company specializing in drug development for central nervous system disorders, aiming to develop effective the

Director, Biostatistics

Location

Massachusetts

Posted

14 days ago

Salary

$195K - $245K / year

Seniority

Mid Level

Postgraduate Degree

Job Description

Director, Biostatistics

MapLight Therapeutics

Title: Director, Biostatistics Location: Burlington, MA Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What You’ll Do: MapLight is looking for an experienced and resourceful Director, Biostatistics. Reporting to Senior Director, Biostatistics, this role will be responsible for the statistical aspects of assigned clinical projects. This is a hands-on role where you will work with internal and external cross-functional study teams, support interaction with Health Authorities, and manage CRO for statistical related deliverables. Responsibilities: - Provide/validate sample size/power calculation and author statistical section of the protocol. - Responsible for the development of study SAP and table/figure/listing shells including overseeing CRO’s work. - Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Regulatory and other functions to meet project deliverables and timelines. - Provide statistical and strategic inputs in documents prepared for regulatory interactions. - Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables. - Contribute to clinical study reports, including authoring of statistical methods and interpretation of the study results. - Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations. Qualifications: - PhD in biostatistics or related discipline with 7+ years, or Master's Degree with 10+ years of experience in the pharmaceutical or biotech industry. - Demonstrated ability and experience in the design, analysis and reporting of clinical trials. - Knowledge of design considerations. Familiarity with CNS endpoints and associated analysis methodologies highly desirable. - Extensive knowledge of FDA, EMA and ICH regulations and industry standards applicable to the design and analysis of clinical trials and regulatory submissions. - Proficient in statistical programming (SAS and R). Experience with trial design software (e.g., EAST). - Ability to concurrently lead statistical efforts for multiple projects. - Understanding data standards, including SDTM and ADaM. - Adept at overseeing statistical services provided by CRO's. - Excellent verbal and written communication skills; Ability to communicate statistical information to non-scientists, willingness to educate internal team. Location: This is a hybrid position with three days per week onsite at our office in Burlington, MA. Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave. Salary Range $195,000 - $245,000 USD EEOC Statement: MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

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Amgen logo

Director of Observational Research

Amgen

Founded in 1980, Amgen (short for Applied Molecular Genetics) is a biotechnology firm focused on developing human therapeutics. As an employer, Amgen has been d

Director14 days ago

Director Observational Research remote type Remote locations United States - Remote time type Full time job requisition id R-244736 Career Category Clinical What you will do Let’s do this. Let’s change the world. In this vital role you will leads the company's strategic planning initiatives and oversees its operational performance, working with leaders across the organization to implement the strategic vision. Do you want an exciting position working with multiple teams to generate real-world evidence supporting a wide variety of business needs? The growing demand for real-world evidence (RWE) from regulatory and reimbursement authorities makes observational research a key component of drug development and commercialization. Amgen's Center for Observational Research (CfOR) is a global organization with an industry-leading analytical capability that generates RWE to support business needs across a product’s lifecycle. CfOR scientists partner with internal collaborators and industry experts to craft, conduct, interpret, and publish observational research that advises decision-making from the early development of a molecule to the design of clinical trials and the safety and efficacy of Amgen medicines. CfOR studies include but are not limited to evidence generation regarding the frequency and distribution of disease, the clinical burden of disease, the natural history or clinical course of the disease, the design of clinical trials, treatment cost, and utilization patterns, and the safety and efficiency of therapeutic interventions. Job Description Amgen is searching for a Director of Observational Research, who will lead an asset in the Oncology therapeutic area. A CfOR director is recognized as a strong scientific contributor and is a first or contributing author for papers in peer-reviewed journals or for internal reports that enhance the company’s mission. 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What we expect of you We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 4 years of scientific experience OR Master's degree and 7 years of scientific experience OR Bachelor's Degree and 9 years of scientific experience OR Associate’s degree and 10 years of scientific experience OR High school diploma / GED & 12 years of scientific experience Preferred Qualifications: •Doctorate in Epidemiology or other subject with high observational research content •Experience in the design, execution, and analysis of observational research studies within Pharmaceutical or Public Health setting •Experience in research to support drug development •Experience in observational research project planning and management •Excellent verbal and writing communication and interpersonal skills •Experience working in multi-disciplinary teams What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. 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