Seattle Genetics

Head of Clinical Programming

Description

Summary:

Seattle Genetics is seeking a highly motivated, skilled and experienced leader of Clinical Programming to provide strategic direction as the group evolves to support the global development of multiple clinical programs.

The Head of Statistical Programming is responsible for the strategic leadership of the clinical programming team supporting multiple drug development programs in all phases of clinical development. The position requires comprehensive knowledge of statistical programming languages (SAS and R) and software, regulatory submission requirements, clinical trial databases, and the drug development process. The individual will be responsible for the work product of a large group of fulltime programmers, contract programmers, and functional service providers. The team is charged with developing programs that generate analysis datasets, produce tables, figures, and listings, validate statistical programs, write general SAS application codes, and prepare documentation for electronic submissions. Lead the critical review of new technologies to improve efficiency and productivity.

Responsibilities:

• Accountable for timely and quality development and validation of all statistical programming deliverables.
• Responsible for quality control and audit readiness of all statistical programming deliverables as well as accuracy and reliability of tables, figures, and listings/
• Co-ordinate, along with programming managers, the activities of all programmers assigned to project(s) internally and externally (FSP, CRO), assess resources, negotiate their priority assignments on the project(s). May act as project manager for some statistical programming deliverables.
• Develops and oversees implementation of programming standards and conventions (e.g. creation of standard macro utilities).
• Ensures all clinical programming functions meet ICH/GCP quality requirements in support of product development.
• Participates in the development and administration of the clinical programming group policies and procedures (SOPs) to ensure compliance with regulatory standards and the achievement of a high quality and efficient clinical programming support function.
• Participates in evaluation and selection of new computing technology and programming practices for continuous improvement of clinical programming. Serves as the departmental designate for SAS system support including working with IT on licensing issues and monitoring hot-fix and technical support news.
• Recruit talent, coach and develop clinical programmers. Designs individual programs to expand direct reports’ knowledge, expertise and technical proficiency.
• Builds and maintains effective working relationship with cross-functional teams including Biostatistics, Data Management, and Clinical Information Systems.
• Ability to summarize and discuss status of deliverables and critical programming aspects (e.g. timelines, scope, resource plan) to Clinical Executive team.
• Experience with budgeting and long-range planning.
• Experience leading a large team of programmers through successful regulatory submissions. Experience managing managers.
• Represent Statistical Programming at audits and in Health Authority (HA) meetings for assigned project(s), or on technical programming aspects in external conferences or groups (e.g. PharmaSUG, CDISC).
• Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend and present at key industy meetings.
• Participate in the ongoing review of the processes used by the Clinical Programming group to ensure processes are complied with and updated as necessary .

Qualifications:

• Master’s or PhD degre in Biostatistics, Statistics, Computer Science or other closely related field.
• Minimum of 10+ years clinical programming within pharmaceutical industry.
• At least 5 years of demonstrated leadership experience and career progression.
• Strong people management skills and supervisory skills gained from direct line management and management of vendors. Proven abilities to lead and manage cross-functional projects, vendors, and people, from concept to completion.
• Strong verbal and written communication skills - ability to clearly and effectively present information.
• An excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, Pharmacovigilance.
• Advanced knowledge of SAS/Base, SAS/Macro, SAS/Stat, SAS/Graph, SAS GTL and SAS/SQL in a windows environment.
• Experience in development and implementation of statistical programming standards and procedures is required.
• Experience using industry standards such as CDASH, SDTM, and ADaM.
• Experience leading teams supporting NDA, EMEA, and Health Canada submissions.
• Flexible to changing priorities, detail-oriented, works well under pressure with initiative to take on unfamiliar tasks.
• Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction.
• Demonstrated ability to accept responsibility for individual and team performance (accountability & ownership).
• Demonstrated ability to evaluate business impact of decisions, follow through on agreed upon decisions, and remain flexible when needed.
• Excellent analytical, problem solving and organization skills with the ability to work on multiple tasks.
• Excellent written and oral communication skills.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

Apply:

Seattle Genetics

Seattle Genetics is an Equal Opportunity Employer

Submitted: 12/02/2017