Abiomed, part of JnJ MedTech, is recruiting for a Sr Statistical Programmer. This position can be located in Boston area, MA or remotely.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
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The senior statistical programmer I will provide technical supports on clinical projects. This position offers the opportunity to lead statistical programming efforts, including developing datasets, creating TLFs for regulatory submissions or publications. Work is performed on the design, development, documentation, and quality control process for SAS programs used to access, extract, transform, review, analyze clinical data and analysis results for Abiomed studies.
Key Responsibilities:
- Reviews and understands study documents, including the Protocol, electronic case Report Forms (eCRFs) and Statistical Analysis Plans (SAPs). Participates in TLF mock shells development and reviews.
- Works with statistician to provide statistical analysis support for clinical studies or ad-hocs, including writing specs and SAS programs to create analysis datasets and outputs, generate and validate TLFs based on SAP and TLF shells.
- Produces study datasets and programs that will help meet CDISC standards.
- Performs quality control according to departmental processes and procedures.
- Solves clinical trial reporting problems and ensures the project tasks are completed accurately with minimum supervision.
- Works with cross-functional team to ensure timely completion of project tasks with high quality and minimum supervision
Qualifications
Education:
BS in Mathematics, Biostats/Statistics, Computer Science/Data Science or related field is required. MS in Biostats/Statistics is preferred.
Experience and Skills:
- Strong SAS programming skill in producing various types of outputs such as TLFs and datasets
- Extensive statistical programming experience in producing deliverables either on scheduled or adhoc basis
- Experience with producing outputs submitted to the FDA and other regulatory agencies
- Excellent organizational skill to prioritize multiple tasks and goals to ensure timely completion
- Attention to details and able to adapt to a fast-paced environment
- Ability to work both independently and in a cross-functional team
- Effective communication (written and verbal) skills to exchange complex information with others
- Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
- Sufficient knowledge in CDISC and SDTM/ADAM for FDA submission compliance and adequate knowledge in clinical trial research methodology, ICH, GCP and regulations
- Requires 3+ years of experience with MS degree or 5+ years with BS in Pharmaceuticals, CRO or Medical device companies
- Experiences in medical device and cardiovascular disease is desirable, but not required
The anticipated base pay range for this position is 108,800 to 147,200. For candidates based in Bay Area, pay range is 124,950 to 169,050.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
- Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
- Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.