Associate Director, Biostatistics at Johnson & Johnson

Danvers, Massachusetts, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Healthcare, MedTech, PharmaceuticalsIndustries

Requirements

PhD or MS in Statistics, Biostatistics, Mathematics or similar area
Minimum of ten years of industry experience in clinical research
Proficient in major statistical programming languages such as SAS and R
Ability to work efficiently in a cross-functional team environment
Ability to work in a highly regulated field according to procedures, rules and SOP
Problem solver, pro-actively offer solutions to challenging issues
Excellent interpersonal skill
Strong oral and written communication skill

Responsibilities

Participate in strategic planning in product development and study design
Develop trial design options and provide guidance and leadership for on-going and planned clinical studies
Participate in planning, design, development, and execution of clinical trial protocols
Develop statistical sections of clinical study documents, including but not limited to clinical study report, statistical analysis plan (SAP), and study synopsis/protocol
Produce and validate statistical analyses and outputs according to SAP
Play a lead role in hypothesis generating process and contribute to statistical methodology in manuscript preparation
Provide statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and publication/presentation efforts related to the project team
Drive the development of internal repository in statistical methodology and statistical programming
Lead and coordinate statistical methodology research in novel trial design
Provide statistical oversight and quality control of deliverables from statistical department
Prepare projects updates for weekly/monthly status meetings
Maintain up to date knowledge of statistical methodology and relevant regulatory guidance
Lead the development and implementation of SOP, work instruction and best practice for statistics department
Play a lead role in development of internal guidelines and SOPs for clinical operation and data management
Oversee and manage statistics and programming vendor
Manage, mentor and develop junior staff of the statistics department

Skills

Key technologies and capabilities for this role

BiostatisticsClinical Trial DesignStatistical AnalysisStatistical Analysis PlanSAPClinical Study ReportHypothesis TestingRegulatory Submissions

Questions & Answers

Common questions about this position

Is remote work available for this position?

Remote work options will be considered on a case-by-case basis for this role based in Danvers, Massachusetts.

What qualifications are required for the Associate Director of Biostatistics role?

A PhD or MS in Statistics is required.

What are the key responsibilities in this biostatistics leadership role?

Responsibilities include providing statistical expertise in clinical trial design, analysis, and interpretation; leading multi-disciplinary teams; developing statistical analysis plans; managing vendors and junior staff; and staying current with regulatory guidance.

Does this role involve leadership and mentoring?

Yes, the role includes leading multi-disciplinary project teams, overseeing vendors, and managing, mentoring, and developing junior staff in the statistics department.

What makes a strong candidate for this Associate Director position?

Candidates with a PhD or MS in Statistics who have expertise in clinical trial design, statistical analysis plans, regulatory submissions, and leadership experience in managing teams and vendors will stand out.

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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