Associate Director, Statistical Programming

BioSpace; King of Prussia (PA); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Health insurance?

401(k) plan?

Tuition assistance?

Job summary

A global biotherapeutics leader based in King of Prussia is seeking an Associate Director of Statistical Programming. This role involves overseeing programming projects, collaborating with cross-functional teams, and ensuring compliance with high standards in clinical data analysis. Candidates must have over 10 years of experience in clinical programming or statistical programming, proficient in SAS, and a strong understanding of CDISC standards. Great communication skills and the ability to work in a multicultural environment are essential. Join a company that values innovation and inclusion.

Qualifications

• At least 10 years of experience in clinical programming/statistical programming within the CRO/pharmaceutical environment.
• Comprehensive understanding of clinical/statistical programming processes and standards.
• Proven ability to work effectively independently or in a team setting.

Responsibilities

• Oversee the delivery of data sets, outputs, and DDT files of clinical trials.
• Plan and lead design and implementation of specifications and programs.
• Mentor programmers and ensure compliance with programming processes.
• Ensure compliance with programming processes and quality standards.
• Lead automation initiatives and explore AI-driven delivery improvements.
• Collaborate with Biometrics and other departments to optimize handoffs.

Skills

Coding in SAS

SAS macro language

Automization of routine programming tasks

Strong interpersonal and communication skills

Collaboration in a matrix environment

Education

BSc in Computer Science, Mathematics, Statistics or related area

Other degrees/certifications considered

Tools

SAS Software

SAS Macros

CDISC standards (CDASH/SDTM/ADaM)

Job description

Position Summary

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. They will 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 ad-hoc requests.
• Mentors programmers allocated to assigned projects and provides feedback to managers of aligned 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.
• Collaborate with Biometrics and other departments to ensure transition points in process are efficient and of high quality.

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 10 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.

Competencies

• 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 and provide leadership 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

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.