The 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. Manages a team of programmers supporting clinical trial and integrated analyses, annual reporting, regulatory responses, publications, HTA requests and other purposes as needed within one or more therapeutic areas.
The individual will work closely with the Senior Director, Clinical and Statistical Programming to advance the internal programming environment and statistical programming processes. Works closely with Statisticians to ensure that deliverables provided by internal resources or outside providers (CROs; FSP providers) are accurate and aligned with CSL standards.
Reporting Relationships: List other positions in the company that are reporting into this position or that this position reports into.
Main Responsibilities and Accountabilities:
- Working with the Biometrics Programming Leadership team, assess upcoming activities and resulting resource needs and allocate projects to people to ensure high quality, timely, delivery. Ensure realistic resource planning.
- Oversee the CRO delivery or manage the in-house programming of data sets, outputs, and DDT files of clinical trials and integrated analysis.
- Coordinating the oversight or in-house programming of exploratory analyses, analyses to support secondary publications, response to regulatory requests, or other ad-hoc requests.
- Manages, hires, and mentors direct reports including annual evaluations and goal setting.
- As a member of the programming leadership team within biometrics, creates, maintains ensures compliance with programming process and strategy to facilitate accurate and timely analysis programming.
- Help bring 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.
- Represents the company in outside professional organizations and meetings.
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 the biotech, pharma, or CRO industries
- Preferred 5 or more years of direct supervisory experience
- Experience with CRO management and/or CRO work experience
- Extensive 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, preferred managing team performing these activities as well
- 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 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
The expected base salary range for this position at hiring is $239,000 - $308,000. 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
