Job description
TITLE:
Statistical Programmer
Title: Statistical Programmer
Reports To: Head, Programming
Location: Remote USA
Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models that have revolutionized modern addiction treatment. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction – a chronic relapsing disease.
Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. The company has a strong pipeline of products and candidates designed to both expand on its heritage in global opioid dependence and address other chronic diseases of addiction – including opiate overdose, alcohol use disorders and cocaine intoxication - as well as related mental health disorders such as schizophrenia.
POSITION SUMMARY:
The Statistical Programmer will be a member of the Statistical Programming function in the Clinical/Data Sciences and Operations group. The main responsibility of this individual is to develop, QC and document Statistical programs to generate the Data Package (Datasets, Tables, Listings, Figures) needed to support regulatory submissions, CSRs, publications and other needs.
ESSENTIAL FUNCTIONS:
- Provide input on protocols, CRF, Database design, edit checks, data review plans, SAPs and Table shells
- Participate to study and joint team meetings
- Review SDTM specifications and SDTM Datasets
- Develop, QC/review and document programming specifications, SAS programs for ADaM datasets and TLFs
- Provide input on CSRs and publications.
- review submission package (Revewer’s guide and DEFINE-XML for SDTM/ADaM for individual studies and integrated efficacy/safety).
- Contribute to the development and implementation of standard programming practices and SOPs.
MINIMUM QUALIFICATIONS:
Education: MS in Biostatistics or a related field with a minimum of 1 years of SAS programming experience in pharmaceutical industry, or BS in Biostatistics or a related field with a minimum of 2 years of SAS programming experience in pharmaceutical industry
Field of Study: Biostatistics/Statistics, Mathematics, or Computer Science
Experience:
- Experience in providing statistical programming support to individual clinical trials
Computer Skills:
- Working knowledge of data management procedures
- Very good in SAS programming, including SAS/BASE with working knowledge of SAS Macro, SAS/STAT, SAS/GRAPH
COMPETENCIES/CONDUCT:
In addition to the minimum qualifications, the employee will demonstrate:
- Strong problem-solving skills
- Good written and verbal communication skills
- Ability to work with a multidisciplinary team, including biostatisticians, and data managers.
PREFERRED QUALIFICATIONS:
- Working knowledge of CDISC standards
BENEFITS:
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes
- 3 weeks’ vacation plus floating holidays and sick leave
- 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay
- U.S. Employee Stock Purchase Plan- 15% Discount
- Comprehensive Medical, Dental, Vision, Life and Disability coverage
- Health and Dependent Care Flex Spending options
- Adoption assistance
- Tuition reimbursement
- Leverage Concierge/personal assistance services
- Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
- Gym, fitness facility and cell phone discounts
- Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.
GUIDING PRINCIPLES:
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled
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