The Senior Statistical Programmer is responsible for providing hands-on support and technical guidance on clinical study teams. The development of study and ad hoc output including, but not limited to: ADaM datasets, tables, figures and listings output and/or QC of requested output is the
main focus of this role. This individual, working closely with the study statistician will be responsible for review and acceptance of contract research organization (CRO) deliverables which are mainly, but not limited to, datasets in submission ready standard format (ADaM), tables, figures and listings and submission packages. This individual will participate in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses. This individual will interface with other departments (eg, Biostatistics, Data Management, Regulatory Operations, Medical Writing, ESP teams) to ensure Standard Operating Procedures are followed and the correct study data are used for all requests. This individual will participate in department and cross functional technology development and process improvement initiatives.
Main Responsibilities and Accountabilities:
Additional tasks
Supports CR&D staff in data analysis requests.
Performs additional statistical analyses including but not limited to:
Job Qualifications and Experience Requirements:
Education
• BSc in Computer Science, Mathematics, Statistics or related area with relevant experience
• Other degrees and certifications considered if commensurate with related programming experience
Experience
• At least 5 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software.
• Understanding of clinical programming and/or statistical programming processes and standards.
• Experiences with statistical programming using the SAS software including development and use of SAS Macros.
• Knowledge in CDISC standards (CDASH, SDTM, ADaM).
• Ability to work effectively in a team setting, and to meet set goals by managing own timelines.
• Ability to work in cross-functional, multicultural and international clinical trial teams.
Competencies
• Good communication and analytical skills.
• Good planning and organizational skills.
• Ability to work successfully in a matrix organizational structure.
• Networking skills and ability to share knowledge and experience amongst colleagues.
• Fluent in English, oral and in writing.
Work Environment: On Site / Hybrid Required to be onsite in work location a minimum of 3 days a week.
The expected base salary range for this position at hiring is $143,000 - $169,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed Work Location for Waltham, MA at the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
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CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
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At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.