Director, Statistical Programming (Remote)
Company: Disability Solutions
Location: Harrisburg
Posted on: April 20, 2024
Job Description:
If you are a Jazz employee please apply via the Internal Career
siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global
biopharmaceutical 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 and novel product candidates, from
early- to late-stage development, in neuroscience and oncology. We
actively explore new options for patients including novel
compounds, small molecules and biologics, and through cannabinoid
science and innovative delivery technologies. Jazz is headquartered
in Dublin, Ireland and has employees around the globe, serving
patients in nearly 75 countries. For more information, please visit
www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
Brief Description: The Director will be responsible for managing
the product leaders and external FSP personnel, overseeing all
ongoing clinical studies, and planning the operational aspects of
all new clinical studies.The Director will support Integrated Data
Analytics and Statistical Programming in statistical analysis and
oversee statistical programming activities for all clinical
studies. The Director will also maintain the programming process
and ensure compliance with SOPs (Standard Operating Procedures) to
produce quality and timely deliverables. In addition, the Director
will use their strong people management skills to provide direct
line management to regular and contract statistical programmers.
Essential Functions
- Oversee Clinical Analysis Reporting Leads for delivery and
execution based on planned timeline and strategic goals.
- Critically review programming strategy and timelines and impact
on the clinical trials.
- Partner with Clinical Analysis Reporting Leads, respect their
responsibilities, and constantly seek diverse perspectives.
Encourage them to take educated risks and find new ways to solve
problems.
- Collaborate with Biostatistics [clinical and medical affairs],
data science, regulatory, clinical development, medical writing,
and other vital functions and represent Statistical programming as
the strategic partner to deliver the following but not limited to:
- A partner who is the advisor for the functional teams and
represents the Statistical Programming
- Deliver the cross-functional process improvement projects as
the single point of contact and or ensure within the Process
improvement framework that they are completed
- Ensure adoption of the new technologies, the process developed
with the Statistical Programming are adopted by the teams in the
other departments
- Be the point of escalation and or contact remove any obstacles
and or barriers for the Clinical Analysis Reporting Leads
- Work collaboratively with multiple product leads and manage
strategic priorities and resources. Make recommendations based on
the workload for hiring FTE and FSP to the leadership team.
- Work closely with management and finance partners to manage and
maintain the statistical programming budget for FSP.
- Perform programming and QC for statistical programming
deliverables as needed.
- Develop statistical programming performance requirements and
measurements according to the Jazz standards. Perform ongoing
assessment/measurement of team performance against set
standards.
- Perform semi-annual and annual performance reviews and
development plans for reports.
- Maintain a positive, results-orientated work environment,
modeling teamwork and communicating to the team in an open,
balanced, and objective manner.Qualifications:
- Bachelor or Master's Degree in Statistics, Mathematics, or
related fields; A Master's degree is preferred
- 15+ years of statistical programming experience in the
Pharmaceutical/Biotech Industry
- 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 and willingness to lead the
implementation of new software (i.e., R, Python)
- Must be highly motivated and able to work well under pressure
and shift priorities independently as a team leader and as a team
member
- Must be willing and able to write and validate SAS code
(study-level programming support) if necessaryJazz 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.
- ntact requiring appropriate business apparel.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 ONLYJazz
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 $192,000-$288,000.
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 candidate's 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 Company's Global Cash Bonus Plan or Incentive
Compensation Plan, as well as discretionary equity grants in
accordance with Jazz's 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:
Keywords: Disability Solutions, Harrisburg , Director, Statistical Programming (Remote), Executive , Harrisburg, Pennsylvania
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