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 Statistical Programming Group is responsible for developing software for the analysis of clinical study data in accordance with departmental SOPs and guidelines.
- Attend multidisciplinary team meetings, representing the programming function.
- Assist statisticians by suggesting algorithms to address novel analysis requests
- Develop programming validation procedures and test plans, as necessary.
- Create and maintain department SOPs related to clinical programming.
- Oversee and validate work of internal contract programmers and external vendors.
- Provide time and resource estimates for project planning.
- Support/provide ad hoc related report for the internal/external team reference.
- Collaborate with other statistical colleagues and study team members to provide input to study data collection and statistical result generation.
- Collaborate with Clinical Operations, Statisticians and Data Management for streamlining process.
- Understand relevant Clinical Trials in order to enhance study team collaboration.
- Create, approve and execute 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.).
- Be accountable for creating, validating and approving CDISC compliant datasets, statistical analysis result, define.xml and corresponding documentation for electronic submission to regulatory agencies.
- Develop programming tools and macros to generate statistical results and displays compliant to submission standard to regulatory agencies.
- Demonstrate SAS programming proficiency.
- Create and document archives of programs, outputs and analysis files.
- Review programming deliverables, draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- 6+ 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
- Interpersonal/teamwork skills for effective interactions
- Self-management skills with focus on results for timely and accurate completion of competing deliverables
- Demonstrate problem solving skills and pay attention in detail
- Solid verbal and written communication skills
- Bachelors degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields. Master’s Degree preferred.
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