Location: United Kingdom - home based
Schedule: Full-Time, Permanent
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….
TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Statistical Programmer to join our client-based team at one of the leading global biopharmaceutical companies. Our client is a world leader, mainly working in the fields of neurology and immunology. Working with both scientists and academics across the globe, they have a focus on new products and a strong science based approach.
CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
Scope of the role:
- Serving as a program or study-level programmer in a defined development program
- Supporting the programming and analysis of a clinical study within current or future company compounds or across multiple compounds/areas of research
- Serving as a lead developer of new technologies, such as innovative visualisation techniques or other non-traditional pharmaceutical programming
Main Job Tasks and Responsibilities:
- Performs as a competent and experienced senior level statistical programmer by functioning as a technical resource, internal statistical programming consultant, and mentor to the statistical programming staff. Works within a Global team
- Leads and supports statistical programming activities for assigned clinical studies, submissions and development initiatives. Coordinates and provides input for assigned project and study teams on timelines and work product required to deliver high quality statistical programming services in close collaboration with CROs
- Provides a high level of effective collaboration for statistical programming initiatives with key team members within GSS and groups outside of GSS (Clinical Data Operations, Technology and Standards (CDOTS), Global Medical Writing, New Medicines, Global Clinical Project Management, therapy areas, Marketing & Market Access and Global Clinical Development & Medical Affairs) to facilitate understanding of statistical programming services and work product
- May program, validate, maintain, and document statistical analysis programs for asset development on the basis of the SAP and of other documents (Protocol, CRF, DMM, ISAP, DAP and ASD) following the company standard operating procedures and working documents
- Where applicable, develops innovative programming methodologies (i.e. interactive visualisation, dashboards, etc.) to facilitate easier interpretation by customer base
- Ensures that submission and study datasets (SDTM and ADaM), tables, figures, listings, statistical output, and program documentation meet standards requirements of regulatory agencies and other departments
- Ensures that datasets, tables, figures, listings, and statistical outputs are produced in an efficient manner, following GSS procedures and standards. Develops specification documentation for datasets (SDTM and ADaM), pooled datasets, tables, figures, listings, and associated metadata
- Supports direction, motivation, and oversight of statistical programming resources (internal and external) for timely delivery of all statistical programming outputs. Mentors and trains other statistical programmers as needed
- Supports development and rollout of new standards and processes with respect to own statistical programming operations team
- Ensures compliance with the 21-CFR Part 11 regulations in terms of validation of SAS programs used for the purpose of statistical reporting of clinical studies
- Contributes to and manages statistical programming timelines and commitments to timelines for the study and/or project
Education and Experience:
- 3-5+ (with Master's degree) to 5-7+ (with Bachelor's degree) years in statistical programming within the Biotechnology and/or Pharmaceutical Industry (including clinical research organisations) with proven successful track record in pharmaceutical development
- Excellent understanding and profound knowledge of statistical programming aspects required for regulatory submissions
- Advanced experience for the statistical programming support for the life cycle of a development compound (from phase I/II through phase IV and post approval activities)
- Proven track record of working within a Standardisation/Automation team
- CDISC, SDTM, ADaM, Define.xml
- Pinnacle 21
- Formedix experience a plus
The Benefits of Working for TalentSource in the UK:
- Pension contribution
- Life assurance
- 25 days holiday
- Child care vouchers
- Eye test vouchers
- Seniority bonus
- Car allowance for defined roles
- Dedicated Line Manager
- Monthly meetings with line manager
- Full performance and development process with end of year reviews
- Team events and end of year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
If you would like to discuss the role before applying through the website @
https://www.talentsourcelifesciences.com/jobs please contact email@example.com for more information.
Who will you be working for?
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
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