The Director of Statistical Programming will be primarily responsible for overseeing statistical ... Develop and validate technical programming specifications for analysis datasets using Alexion or ...
The Director of Statistical Programming will be primarily responsible for overseeing statistical ... Develop and validate technical programming specifications for analysis datasets using Alexion or ...
The Director of Statistical Programming will be primarily responsible for overseeing statistical ... Develop and validate technical programming specifications for analysis datasets using Alexion or ...
The Director of Statistical Programming will be primarily responsible for overseeing statistical ... Develop and validate technical programming specifications for analysis datasets using Alexion or ...
The Director of Statistical Programming will be primarily responsible for overseeing statistical ... Develop and validate technical programming specifications for analysis datasets using Alexion or ...
The Director of Statistical Programming will be primarily responsible for overseeing statistical ... Develop and validate technical programming specifications for analysis datasets using Alexion or ...
Must have a valid State Drivers License Knowledge of the physiology and psychology of the older adult. Experience in program design, planning and implementation is desired. Equal Opportunity Employer ...
Must have a valid State Drivers License Knowledge of the physiology and psychology of the older adult. Experience in program design, planning and implementation is desired. Equal Opportunity Employer ...
Project Director
Wilmington, DE · On-site
Project Director FLSA Status: Salaried, Exempt Status: Full-Time Position Summary The Project ... Validate scopes of work with insurance adjusters, consultants, TPA's and property owners/managers ...
Project Director
Wilmington, DE · On-site
Project Director FLSA Status: Salaried, Exempt Status: Full-Time Position Summary The Project ... Validate scopes of work with insurance adjusters, consultants, TPA's and property owners/managers ...
Activities Director
Newark, DE · On-site
$62K/yr
... and direct the Connections program of the community. Requirements: • A High School Diploma ... Computer literate. • Must have a valid State Drivers License • Knowledge of the physiology and ...
Activities Director
Newark, DE · On-site
$62K/yr
... and direct the Connections program of the community. Requirements: • A High School Diploma ... Computer literate. • Must have a valid State Drivers License • Knowledge of the physiology and ...
Project Director
Wilmington, DE · On-site
Position Summary The Project Director (PD) is a client-facing, revenue-generating, role responsible ... Validate scopes of work with insurance adjusters, consultants, TPA's and property owners/managers ...
Project Director
Wilmington, DE · On-site
Position Summary The Project Director (PD) is a client-facing, revenue-generating, role responsible ... Validate scopes of work with insurance adjusters, consultants, TPA's and property owners/managers ...
Provides training and conducts skill/competency validation and/or medication pass observations in accordance with State regulations. * Provides supervision and oversight for C.N.A. and other direct ...
Provides training and conducts skill/competency validation and/or medication pass observations in accordance with State regulations. * Provides supervision and oversight for C.N.A. and other direct ...
Provides training and conducts skill/competency validation and/or medication pass observations in accordance with State regulations. * Provides supervision and oversight for C.N.A. and other direct ...
Provides training and conducts skill/competency validation and/or medication pass observations in accordance with State regulations. * Provides supervision and oversight for C.N.A. and other direct ...
The Area Director (AD) is responsible for reaching the Sales and Profit goals in the assigned Area ... A valid fire arms permit or ability to pass applicable firearms licensing requirements * A valid ...
The Area Director (AD) is responsible for reaching the Sales and Profit goals in the assigned Area ... A valid fire arms permit or ability to pass applicable firearms licensing requirements * A valid ...
Project Director, FEP
Dover, DE · On-site
Description Project Director, FEP Hybrid in Operating Territory: DE, PA, VA, NC, SC, GA, FL, TX ... Valid State Driver's license * Advanced knowledge of large-scale capital program management ...
Project Director, FEP
Dover, DE · On-site
Description Project Director, FEP Hybrid in Operating Territory: DE, PA, VA, NC, SC, GA, FL, TX ... Valid State Driver's license * Advanced knowledge of large-scale capital program management ...
We are seeking an experienced Director- Pharmaceutical Production Operation, to provide end-to-end ... Lead validation lifecycle: PPQ strategy/execution, cleaning validation, lyophilize cycle ...
We are seeking an experienced Director- Pharmaceutical Production Operation, to provide end-to-end ... Lead validation lifecycle: PPQ strategy/execution, cleaning validation, lyophilize cycle ...
Director of Pharmaceutical Production Operations
$160K - $200K/yr
Direct Hire/Permanent We are seeking an experienced Director to provide end-to-end leadership for ... Lead validation lifecycle: PPQ strategy/execution, cleaning validation, lyophilize cycle ...
Quick apply
Director of Pharmaceutical Production Operations
$160K - $200K/yr
Direct Hire/Permanent We are seeking an experienced Director to provide end-to-end leadership for ... Lead validation lifecycle: PPQ strategy/execution, cleaning validation, lyophilize cycle ...
Overview We are seeking an experienced Director- Pharmaceutical Production Operation, to provide ... Lead validation lifecycle: PPQ strategy/execution, cleaning validation, lyophilize cycle ...
Overview We are seeking an experienced Director- Pharmaceutical Production Operation, to provide ... Lead validation lifecycle: PPQ strategy/execution, cleaning validation, lyophilize cycle ...
We are seeking an experienced Director- Pharmaceutical Production Operation, to provide end-to-end ... Lead validation lifecycle: PPQ strategy/execution, cleaning validation, lyophilize cycle ...
We are seeking an experienced Director- Pharmaceutical Production Operation, to provide end-to-end ... Lead validation lifecycle: PPQ strategy/execution, cleaning validation, lyophilize cycle ...
Must have a valid driver's license, current Defensive Driving certificate, and proof of insurance ... Director. PRIMARY WORK LOCATION: Most duties and functions will be performed in an office ...
Must have a valid driver's license, current Defensive Driving certificate, and proof of insurance ... Director. PRIMARY WORK LOCATION: Most duties and functions will be performed in an office ...
The Associate Director for Drug Substance Quality Assurance (DS-QA) role will involve establishing ... Must have experience in supporting tech transfer or process validation either internally or ...
New
The Associate Director for Drug Substance Quality Assurance (DS-QA) role will involve establishing ... Must have experience in supporting tech transfer or process validation either internally or ...
New
The Associate Director for Drug Substance Quality Assurance (DS-QA) role will involve establishing ... Must have experience in supporting tech transfer or process validation either internally or ...
The Associate Director for Drug Substance Quality Assurance (DS-QA) role will involve establishing ... Must have experience in supporting tech transfer or process validation either internally or ...
Job Summary (Primary function) The Director, Antibody Discovery implements, develops, and operates ... validation and discovery programs. • Utilize Contract Research Organizations (CROs) and internal ...
Job Summary (Primary function) The Director, Antibody Discovery implements, develops, and operates ... validation and discovery programs. • Utilize Contract Research Organizations (CROs) and internal ...
Direct external collaborations for the discovery and optimization of biotherapeutic compounds ... Collaborate with immunologists and pharmacologists to drive target validation and discovery ...
Direct external collaborations for the discovery and optimization of biotherapeutic compounds ... Collaborate with immunologists and pharmacologists to drive target validation and discovery ...
Director Validation information
See Delaware salary details
$26.8K - $41.3K
4% of jobs
$41.3K - $55.9K
6% of jobs
$55.9K - $70.4K
8% of jobs
$79.7K is the 25th percentile. Wages below this are outliers.
$70.4K - $85K
9% of jobs
$85K - $99.6K
8% of jobs
$99.6K - $114.1K
6% of jobs
$114.1K - $128.7K
4% of jobs
The median wage is $133.9K / yr.
$128.7K - $143.2K
7% of jobs
$143.2K - $157.8K
6% of jobs
$157.8K - $172.3K
11% of jobs
$174.1K is the 75th percentile. Wages above this are outliers.
$172.3K - $186.9K
28% of jobs
$26.8K
$126.9K
$186.9K
How much do director validation jobs pay per year?
What are the typical daily responsibilities of a Director Validation in a regulated industry?
A Director Validation typically oversees the planning, execution, and review of validation projects to ensure compliance with regulatory requirements. Daily responsibilities include leading teams, reviewing validation protocols and reports, coordinating with quality, engineering, and regulatory departments, and addressing any deviations or issues that arise during validation activities. The role may also involve direct communication with regulatory agencies during audits and inspections. This ensures products or processes meet the highest standards of quality and regulatory compliance, ultimately supporting the company’s overall operational success.
What does a Director of Validation do?
A Director of Validation oversees the validation processes in industries like pharmaceuticals, biotechnology, or medical devices to ensure compliance with regulatory standards. They develop and implement validation strategies for equipment, processes, and systems, ensuring they meet quality and safety requirements. This role involves managing validation teams, coordinating with regulatory bodies, and maintaining documentation to support audits and inspections. The Director also ensures adherence to industry guidelines such as FDA, EMA, or ISO standards.
What are the key skills and qualifications needed to thrive in the Director Validation position, and why are they important?
To thrive as a Director Validation, you need extensive experience in validation processes, regulatory compliance, quality assurance, and a relevant scientific or engineering degree. Familiarity with industry standards, validation lifecycle management software, and certifications such as Six Sigma or PMP are highly valued. Strong leadership, strategic thinking, and excellent communication skills help to drive complex projects and foster cross-functional collaboration. These skills are vital to ensuring validated processes meet regulatory standards and support organizational goals efficiently.
Full-time
Medical, Dental, Vision, Retirement, PTO
Re-posted 4 days ago
Job description
The Director of Statistical Programming will be primarily responsible for overseeing statistical programming activities for multiple clinical studies within multiple Therapeutic Areas, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverables. He/she must possess extensive experience and proven skills in the use of SAS within a Statistical Programming environment and complete knowledge and understanding of the statistical programming processes, procedures, and roles. He/she will use knowledge of CDISC SDTM and ADaM standards to support Biostatistics in statistical analysis, including generating analysis data listing, tables, and figures and create all files necessary to support an electronic submission in the eCTD format. Additionally, the successful candidate will use his/her strong people management skills and supervisory skills to provide direct line management to statistical programmers and external partners, identify training needs and opportunities for optimizing staff utilization and employing the most efficient practices. He/she must be able to identify project resource requirement needs and manage large external provider contract budgets. He/she may be responsible for the direct-line management of the statistical programmers through Associate Director level staff.
You will be responsible for:
- Serve as the Lead Programmer and Manager of the statistical programming efforts for a compound / indication.
- Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
- Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.
- Develop and validate technical programming specifications for protocol specific efficacy tables, listings, figures/graphs.
- Independently develop and validate programs that generate protocol specific efficacy tables, listings, figures/graphs using Alexion specifications.
- Ensuring that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit.
- Provide secondary reviews of Statistical Programming deliverables.
- Directly support the Statistical Programming Sr. Director in all aspects of the management and development of the Statistical Programming team.
- Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary.
- Create and/or review programming plans and ensure appropriate resource allocation and prioritization.
- Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies.
- Manage adherence to all company policies, SOPs, and other controlled documents; and ensure all programming activities adhere to departmental standards.
- Assume direct line management responsibility of the statistical programmers, conducting performance reviews, setting and regularly reviewing objectives, providing guidance and mentoring, and developing and regularly reviewing training and career development plans.
- Plan and manage department budget. Forecast quarter, annual, and 3-5 year budget. Participate in strategic development meetings across departments.
- Evaluate, develop, revise, implement and ensure compliance to functional guidelines, policies, and SOPs.
- Collaborate across all functional areas to ensure programming needs are met with specific regards to study data specifications, applications and computing environment support.
- Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support.
- Collaborate closely with Preferred Vendor management in terms of governance, recruiting needs, contract development and signature, and any other partnership requirement that may arise.
- Any other activities as required.
Any other activities as required.
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
You will need to have:
- A bachelor's degree with a minimum of 10+ years statistical programming experience in the CRO or Pharmaceutical Industry.
- 7+ years people and / or project management experience in the CRO or Pharmaceutical Industry.
- Advanced SAS programming skills in a clinical and statistical data environment across multiple therapeutic areas.
- Thorough understanding of relational databases and their correlation to submission ready database structure.
- Strong project management skills and experience with scope management, resource management, financial management, project planning and resource allocation
- Significant experience in a leadership capacity with a focus on identifying, leading and advancing talent.
- Experience working in a clinical development organization with a heavy emphasis on support of multiple, ongoing projects
- Thorough understanding of pharmaceutical clinical development (i.e. understanding of statistical concepts, techniques, and clinical trial principles) and ability to manage and lead regulatory submissions.
- Thorough understanding of industry standards such as CDISC and 21CFR Part 11.
- Strong ability to solve problems, recommend process improvements, and execute on process improvements.
- Ability to lead and influence teams
- Excellent verbal and written communication skills in a global environment.
- Proven ability to work with cross functional teams, specifically Data Management, Biostatistics, Epidemiology, Clinical Operations, and Pharmacovigilance to initiate, lead and execute new initiatives and process improvements.
- Recognize behaviors that align with our values critical to the success of our employees, mission, and business objectives.
We would prefer for you to have:
- BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area.
- Competencies
- Accountability
- Collaboration
- Decision Quality
- Drive for Results
- Perseverance
- Problem Solving
- Informing
- Peer Relationships
- Time Management
- Building Effective Teams
- Managing Through Systems
The annual base pay (or hourly rate of compensation) for this position ranges from $165,095.20 - $247,642.80. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
27-Jul-2026
Closing Date
02-Aug-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
About Alexion
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
1,001 - 5,000 Employees
Headquarters location
Boston, MA, US
Year founded
1992