What are the responsibilities and job description for the Associate Director, Statistical Programming (w/m/d) position at BioSpace?
Position Purpose
The Associate Director, Statistical Programming provides leadership and expertise in driving the development and maintenance of the CSL statistical programming capabilities which is required to meet regulatory obligations. The individual will work closely with the Director, Statistical Programming to ensure all assigned Statistical Programming tasks are managed to completion. Work closely with Statisticians to ensure that deliverables provided by internal resources or outside providers (CROs; FSP providers) are accurate and aligned with CSL standards.
This individual may manage a Therapeutic Areas (TA) or programs within or across TAs working with the Statistics TA lead to ensure all work required in the TA is completed within the project timelines with high quality.
Main Responsibilities And Accountabilities
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.
The Associate Director, Statistical Programming provides leadership and expertise in driving the development and maintenance of the CSL statistical programming capabilities which is required to meet regulatory obligations. The individual will work closely with the Director, Statistical Programming to ensure all assigned Statistical Programming tasks are managed to completion. Work closely with Statisticians to ensure that deliverables provided by internal resources or outside providers (CROs; FSP providers) are accurate and aligned with CSL standards.
This individual may manage a Therapeutic Areas (TA) or programs within or across TAs working with the Statistics TA lead to ensure all work required in the TA is completed within the project timelines with high quality.
Main Responsibilities And Accountabilities
- Working with the Director, Programming to assess upcoming activities and resulting resource needs and ensure high quality, timely, delivery of assigned projects. Ensure realistic project planning.
- Oversee the CRO delivery or manage the in-house programming of data sets, outputs, and DDT files of clinical trials and integrated analysis.
- Plans and leads the design and implementation of complex specifications and programs for applications designed to analyze and report complex clinical trial data in CDISC format.
- Coordinating the oversight or in-house programming of exploratory analyses, analyses to support secondary publications, response to regulatory requests, or other adhoc requests.
- Mentors programmers allocated to assigned projects and provides feedback to managers of these team members as needed.
- As a project or program leader ensures compliance with programming process and strategy to facilitate accurate and timely programming.
- Test and implement state of the art programming methods and tools to the organization and drive automation of delivery, including AI.
- BSc in Computer Science, Mathematics, Statistics or related area with relevant experience
- Other degrees and certifications considered if commensurate with related programming experience
- At least 9 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software.
- Comprehensive understanding of clinical programming and/or statistical programming processes and standards.
- Advanced Experiences with statistical programming using the SAS software including development and use of SAS Macros.
- Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
- Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
- Experience in working in cross-functional, multicultural and international clinical trial teams.
- Coding in SAS, including SAS macro language
- Interest and/or experience in expanding beyond SAS as the primary programming delivery tool
- Experience in and/or passion for automatization of routine programming tasks
- Broad knowledge of clinical development and processes
- Strong interpersonal and communication skills (verbal and written in English), comfortable around senior management
- Ability to collaboratively work in matrix environment
- A solutions oriented mindset
- Fluency in technical requirements for CDISC compatible datasets and DDT files
- Presentations of programming techniques at professional conferences is a plus
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.