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Driving innovation to eliminate cigarettes

Manager, Biostatistics

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THE COMPANY:

JUUL’s mission is to improve the lives of the world’s one billion adult smokers by driving innovation to eliminate cigarettes. JUUL is the number one US-based vapor product. Headquartered in San Francisco and backed by leading technology investors including Tiger Global, Fidelity Investments and Tao Invest LLC, JUUL Labs is disrupting one of the world’s largest and oldest industries.

We’re an exceptional team with backgrounds in technology, healthcare, CPG and biotech, and we’re growing rapidly to deliver on our mission. We’re actively looking to hire the world’s best scientists, engineers, designers, product managers, supply chain experts, customer service and business professionals.

ROLE AND RESPONSIBILITIES:

The Manager, Biostatistics performs duties of a project or trial statistician to support clinical development projects/trials as required. The person provides statistical input and guidance into the development of clinical protocols, and assures well-designed clinical trials; provides statistical expertise to analyze, interprets and communicates the results of clinical trials, and (non) clinical experiments including Epidemiology and survey The role also takes on statistical responsibility in the preparation of regulatory interactions. Pharmaceutical Industry experience is required. CRO experience would be considered. Must have good communication skills, ability to collaborate across functional areas and solid clinical statistical experience.

* Performs duties of a project or trial statistician to support multiple clinical development projects/trials.
* Provides statistical input during protocol development to ensure adequacy of proposed study designs with respect to statistical feasibility.
* Develops statistical sections of study protocol and statistical analysis plan.
* Performs statistical analyses of data and interpret results to ensure validity of conclusions.
* Ensures achievement of statistical deliverables and milestones in coordination with other functions including clinical research, statistical programming, regulatory, data management, and medical writing.
* Guides CRO biostatistics for outsourced projects, and assure compliance with the specifications by reviewing/validating vendors' deliverables.\
* Collaborates with data management and clinical operations over the course of trials to provide statistical input to study conducts and database development as well as data collection/cleaning.
* Collaborates with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation.
* Interacts with medical writing in development of statistical and integrated clinical/statistical reports and other documents containing statistical information.
* Contributes to the development of functional-level standards, tools, and templates.

PERSONAL AND PROFESSIONAL QUALIFICATIONS:

Educational Requirements: Graduate degree in Statistics, Biostatistics, or equivalent.

* 5+ years of experience with at least 3 years of experience of industry experience is required; pharmaceutical experience is strongly preferred.
* Excellent written and verbal communication skills.
* Thorough knowledge of statistical methodology, processing clinical trial information and drug development process
* Evidence of strong teamwork capabilities.
* Understand responsibilities of other functional areas (e.g., statistical programming, clinical, data management, medical writing) and work with their representatives.
* Project management skill from statistical perspective.
* Ability to review, understand, and work with data from multiple sources.
* Experience in industry data standards, such as CDISC/SDTM and ADaM.
* Knowledgeable of regulatory (e.g., FDA, ICH) requirements. Experience supporting regulatory submissions in the US and EU and dealing with requests from Health Authorities.
* Proficient with SAS, and R or other statistical software.

JUUL LABS PERKS & BENEFITS:

* A place to grow your career. We’ll help you set big goals - and exceed them
* People. Work with talented, committed and supportive teammates
* Equity and performance bonuses. Every employee is a stakeholder in our success
* Boundless snacks and drinks
* Cell phone subsidy, commuter benefits and discounts on JUUL products
* Excellent medical, dental and vision benefits
* Location. Work in the heart of San Francisco, one of the world’s greatest cities

Vapor, JUUL, Work Culture, Fast Paced, Start-up, Growth, Vape, Technology, Software, Hardware, Consumer Electronics, Manufacturing, Design, Product, Disruptive, Revolutionary, Cutting Edge, App, Android, eCommerce, B2C, San Francisco, Bay Area, IoT, San Jose, Los Angeles

Healthcare benefits

Excellent medical, dental and vision benefits for you and your family.

401k

With 4% matching.

Equity benefits

Equity and performance bonuses. Every employee is a stakeholder in our success.

Snacks & drinks

Boundless snacks and drinks. Catered lunch daily.

Commuter benefits

Cell phone subsidy and commuter benefits.

A place to grow

We’ll help you set big goals, then watch you exceed them.

The people

Work with talented, committed and supportive teammates.

JUUL Labs at a glance

Driving innovation to eliminate cigarettes

JUUL Labs focuses on E-Commerce, Consumer Goods, B2B, Consumer Electronics, and Leisure. Their company has offices in San Francisco. They have a very large team that's between 1001-5000 employees. To date, JUUL Labs has raised $14.407B of funding; their latest round was closed on September 2019.

You can view their website at https://www.juul.com or find them on Twitter and LinkedIn.

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