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
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:
- Collaborates with the study statistician to design data structure and specifications for adhoc and study deliverables, including, but not limited to ADaM datasets, Tables, Figures, Listings and Analysis Submission content. Leads the production and validation efforts for the designed output; this may include oversight of work by CROs.
- Collaborates with peers and statisticians to ensure the quality and accuracy –thus submission readiness –of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml). Supports the review of related deliverables when provided by CROs.
- Leads requested efforts for pooled and exploratory analyses, working closely with clinical programming team and their collection of legacy data.
- Leads the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures, and listings) when not provided by CRO.
- Leads the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.
- Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
- Works closely with clinical study teams to ensure that project timelines are met with high quality deliverables.
Additional tasks:
Supports CR&D staff in data analysis requests.
Performs additional statistical analyses, including but not limited to:
- Support responses to regulatory agencies,
- Generate an integrated summary of safety and efficacy,
- Support publications and presentations,
- Support planning and reporting of clinical trials via exploratory analyses of available data,
- Replicate CRO and CSL statistician analyses for QC
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.
The expected base salary range for this position at hiring is $143000 - $169000 USD for the Waltham, MA USA location. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the Waltham, MA location as of 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
About CSL Behring
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.
You Belong at CSL
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.
