Senior Statistical Programmer

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 independent e-cigarette, selling over four million JUULpods per month. 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 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 Clinical Programming Group within the Data Management and Biostatistics organization is responsible for developing software for the analysis of clinical study data in accordance with departmental SOPs and guidelines.

The Senior Statistical Programmer will:

• Attend multidisciplinary team meetings, representing the programming function.
• Create or review and approve programming plans at study and project level.
• Provide input on key study related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.)
• Create or review and approve CDIS compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
• Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies
• Assist statisticians by suggesting algorithms to address novel analysis requests
• Develop software validation procedures and test plans, as necessary.
• Create and document archives of software, outputs, and analysis files.
• Create and maintain department SOPs related to clinical programming.
• Review draft clinical reports, journal articles, slide presentations, and other documents to assure
• that results are reported accurately.
• Oversee work of internal contract programmers and external vendors.
• Provide time and resource estimates for project planning.

PERSONAL AND PROFESSIONAL QUALIFICATIONS:
Education: Bachelors degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields. Master’s Degree preferred.

• 3+ years of experience in developing software for clinical trials using the SAS system
• Skilled in programming with SAS. Knowledge of additional programming languages a plus.
• Good knowledge of statistics and drug development process
• Experience as a lead programmer for NDAs/BLAs
• Experience overseeing the work of internal contractors and external vendors (CROs)
• Experience in pharmacokinetics/pharmacodynamics modeling a plus
• Familiarity with CDISC standards, including SDTM and ADaM models
• Solid verbal and written communication skills

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

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