Job Details

Senior Director, Statistical Programming

Nottinghamshire Nottingham United Kingdom, NG14 Permanent

Posted: 18 hours ago


* The Senior Director, Statistical Programming will provide strategic direction and technical expertise for the statistical programming department. To establish the optimal operational framework ensuring statistical programming deliverables are completed to a high quality, on time, and on-budget. To anticipate regulatory and industry changes to function. *

Tasks may include but are not limited to:

* Provide global innovative and creative leadership of the department, across sites and countries, including setting the strategic direction and leading change.
* Plan and develop overall strategies for the future of statistical programming including system and resource needs.
* Assume overall responsibility for the efficiency of the statistical programming department, utilizing metrics an quality and efficiency and feedback from internal and external customers
* Identify and implement process improvements and efficiencies within the department and cross-functionally with related departments.
* Monitor departmental budgets and have oversight of PPR's, ensuring programming team is adhering to trial budgets and timelines.
* Be responsible for staff allocation within the department, ensuring sufficient expertise and delegating responsibility appropriately.
* Identify the department's training requirements and provide or source training as required.
* Supervise, coach and mentor statistical programming staff, managing performance appraisals and development reviews as appropriate.
* Ensure the department statistical programming activities are performed in compliance with relevant GCP and Quality Systems standards, CDISC standards and specifically with FDA Quality System Regulation (including 21CFR Part 11}.
* Lead the procurement and installation of new software with computing and external software providers, including oversight or management of software validation and documentation to meet company standards and regulatory requirements.
* Provide technical advise and support on statistical programming topics to other departments.
* Represent the function externally through developing/managing customer relationships and attending/participating external meetings/conferences.
* Provide support for the bidding process, including contribution to budget review, bid defense meetings and development of the budget algorithm for stats programming activities. Also provides consultation on pricing and budget algorithms.
* Provide consultancy, mentoring and guidance to Programmers and statisticians on programming and associated software support.
* Maintain a high level of expertise in: SAS applications (e.g. BASE, MACRO, GRAPH, ODS, SQL}, other software applications (e.g. Excel, Visual Basic, Word) and regulatory standards in computer systems, systems validation, Good Clinical Practice, clinical / statistical reporting and regulatory submission requirements.
* Assist with Quality Assurance and Audit requirements
* Perform all activities in compliance with WCT and agreed sponsor quality system standards, relevant GCP standards and specifically with FDA Quality System Regulation (including 21CFR Part 11).


* The job holder must be computer literate and numerate with a proven ability to adapt to various computer systems
* The job holder should have well developed consultancy and facilitation skills together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, building capability, embracing innovation and change and participative leadership.
* The job holder should have a broad experience of developing the role of statistical programming across a business including extensive experience in all phases (l to IV) of Clinical Research applications along with expert knowledge of the applicable regulatory standards.


* Educated to degree level or equivalent experience
* At least 12 years of relevant statistical programming experience, including advanced SAS programming skills with deep knowledge of SAS/Macro, Proc Tabulate, Proc Report and ODS. Good working knowledge in SAS/Graph, Proc SQL.
* Excellent written and verbal communications skills and strong attention to detail. Ability to discuss technical topics with non-programmers.
* Strength of knowledge across a range of data management (e.g. data validation, audit trails, laboratory data transfer and coding dictionaries, electronic data capture) and statistical (e.g. data restructuring, data summary, analysis and reporting) applications.
* Experienced in guiding/mentoring/managing other programmers and managers
* Excellent time management skills with the ability to develop and direct complex resourcing needs.
* Excellent knowledge of budgets, revenue recognition and invoicing.
* Ability to define strategies that align to and contribute to the department's and organization's strategic plan.
* Proven ability to prioritize, manage multiple projects and issues simultaneously, provide flexible and creative solutions, use sound independent judgement and take initiative.

Job Details

Sun, 09 Jan 2022 19:00:00 EST
Nottingham, Nottinghamshire, United Kingdom