Senior Director, Head of Clinical Statistical Programming
AppCast, Oceanside, CA, United States
If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to
transform the lives of patients and their families. We are dedicated to developing
life-changing medicines for people with serious diseases — often with limited or no
therapeutic options. We have a diverse portfolio of marketed medicines, including leading
therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
Our patient-focused and science-driven approach powers pioneering research and development
advancements across our robust pipeline of innovative therapeutics in oncology and
neuroscience. Jazz is headquartered in Dublin, Ireland with research and development
laboratories, manufacturing facilities and employees in multiple countries committed to
serving patients worldwide. Please visit
www.jazzpharmaceuticals.com
for more information.
The Senior Director, Head of Clinical Statistical Programming leads the Statistical Programming Organization reporting into the VP of Data Science, Evidence and Value Generation and Global Medical and Scientific Affairs. The Sr Director is accountable for overseeing statistical programming activities for all Clinical Development studies. The Sr Director will also manage all regulatory submission activities to health authorities around the world for statistical programming.
The Sr Director will also maintain programming infrastructure and ensure compliance with SOPs to produce quality and timely deliverables.
The Sr Dir will be tasked with overseeing the automation of much of the statistical programming workflow in partnership with the Enterprise R+D AAAI organization.
The Sr Director will use his/her strong people management skills to provide direct line management to regular and contract statistical programmers.
Essential Functions
Lead, manage, develop, support and mentor statistical programming group within the Data Science Department
Represent Clinical Statistical Programming and Data Science in cross functional projects and processes and Jazz as well as outside of Jazz.
Lead and oversee development and implementation of the programming standards and practices to ensure alignment between department’s strategic direction and company’s R&D strategies
Oversee the development and implementation of statistical programming SOPs and work instructions, including program validation and documentation
Anticipate resource needs and work with management to ensure adequate resource allocation for all projects
Participate in vendor qualification/selection and monitor vendor performance
Responsible for providing programming leadership for preparation of datasets and TLFs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
Ensure that the filing of study documentation is maintained to the standard required according to processes and is acceptable for audit
Assume direct line management responsibility of the clinical statistical programmers
Independently develop and validate programs that generate protocol-specific efficacy tables, listings, figures/graphs using specifications, if warranted
Provide secondary reviews of Clinical Statistical Programming deliverables, if warranted
Promote collaborations and build teamwork spirit within the department and cross-functionally
Keep abreast of literature and advancements in SAS, R, Python and emerging programming languages
Oversee the automation and implementation of AI in the statistical programming workflow
Required Knowledge, Skills, and Abilities
10+ years of statistical programming experience in the Pharmaceutical/Biotech Industry or CRO with 7+ years of supervisory experience
Experience leading submissions to worldwide regulatory agencies (FDA, EMA, PMDA, etc)
Demonstrated strong leadership qualifications, including strategic thinking, contingency planning, problem solving, and dispute resolution skills
Ability to execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment
Clear and effective verbal and written communications across disciplines in the company
Extensive experience managing CROs or FSPs to scale up or down as the workload permits
Good knowledge of drug development regulations pertinent to statistical analysis
Solid experience with global clinical trial practices, procedures, and methodologies
Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
Excellent SAS programming skills
Must be highly-motivated and able to work well under pressure and shifting priorities independently as a team leader and as a team member
Responsible for providing programming leadership for preparation of datasets and TLFs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
Required/Preferred Education and Licenses
Bachelor’s Degree is required or a Master’s Degree or higher is preferred in Statistics, Mathematics, or related fields.
LI-Remote
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $252,000.00 - $378,000.00
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidates expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Companys Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazzs Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here:
https://careers.jazzpharma.com/benefits.html .
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to
transform the lives of patients and their families. We are dedicated to developing
life-changing medicines for people with serious diseases — often with limited or no
therapeutic options. We have a diverse portfolio of marketed medicines, including leading
therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
Our patient-focused and science-driven approach powers pioneering research and development
advancements across our robust pipeline of innovative therapeutics in oncology and
neuroscience. Jazz is headquartered in Dublin, Ireland with research and development
laboratories, manufacturing facilities and employees in multiple countries committed to
serving patients worldwide. Please visit
www.jazzpharmaceuticals.com
for more information.
The Senior Director, Head of Clinical Statistical Programming leads the Statistical Programming Organization reporting into the VP of Data Science, Evidence and Value Generation and Global Medical and Scientific Affairs. The Sr Director is accountable for overseeing statistical programming activities for all Clinical Development studies. The Sr Director will also manage all regulatory submission activities to health authorities around the world for statistical programming.
The Sr Director will also maintain programming infrastructure and ensure compliance with SOPs to produce quality and timely deliverables.
The Sr Dir will be tasked with overseeing the automation of much of the statistical programming workflow in partnership with the Enterprise R+D AAAI organization.
The Sr Director will use his/her strong people management skills to provide direct line management to regular and contract statistical programmers.
Essential Functions
Lead, manage, develop, support and mentor statistical programming group within the Data Science Department
Represent Clinical Statistical Programming and Data Science in cross functional projects and processes and Jazz as well as outside of Jazz.
Lead and oversee development and implementation of the programming standards and practices to ensure alignment between department’s strategic direction and company’s R&D strategies
Oversee the development and implementation of statistical programming SOPs and work instructions, including program validation and documentation
Anticipate resource needs and work with management to ensure adequate resource allocation for all projects
Participate in vendor qualification/selection and monitor vendor performance
Responsible for providing programming leadership for preparation of datasets and TLFs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
Ensure that the filing of study documentation is maintained to the standard required according to processes and is acceptable for audit
Assume direct line management responsibility of the clinical statistical programmers
Independently develop and validate programs that generate protocol-specific efficacy tables, listings, figures/graphs using specifications, if warranted
Provide secondary reviews of Clinical Statistical Programming deliverables, if warranted
Promote collaborations and build teamwork spirit within the department and cross-functionally
Keep abreast of literature and advancements in SAS, R, Python and emerging programming languages
Oversee the automation and implementation of AI in the statistical programming workflow
Required Knowledge, Skills, and Abilities
10+ years of statistical programming experience in the Pharmaceutical/Biotech Industry or CRO with 7+ years of supervisory experience
Experience leading submissions to worldwide regulatory agencies (FDA, EMA, PMDA, etc)
Demonstrated strong leadership qualifications, including strategic thinking, contingency planning, problem solving, and dispute resolution skills
Ability to execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment
Clear and effective verbal and written communications across disciplines in the company
Extensive experience managing CROs or FSPs to scale up or down as the workload permits
Good knowledge of drug development regulations pertinent to statistical analysis
Solid experience with global clinical trial practices, procedures, and methodologies
Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
Excellent SAS programming skills
Must be highly-motivated and able to work well under pressure and shifting priorities independently as a team leader and as a team member
Responsible for providing programming leadership for preparation of datasets and TLFs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
Required/Preferred Education and Licenses
Bachelor’s Degree is required or a Master’s Degree or higher is preferred in Statistics, Mathematics, or related fields.
LI-Remote
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $252,000.00 - $378,000.00
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidates expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Companys Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazzs Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here:
https://careers.jazzpharma.com/benefits.html .