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MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.
We are now seeking a Senior SAS Programmer to work across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines
.
We require someone with excellent knowledge of CDISC SDTM and ADaM implementation guidelines who can work independently in this area; producing, reviewing and updating complex dataset specifications (including efficacy); creating and debugging complex macros; reviewing Statistical Analysis Plans (SAPs), including study specific ISS/ISE and DSMB SAPs and output shells with a view to commenting from a programming perspectiv
e.
An excellent teamwork ethos, proactive at managing workload, willingness to help others and learn new skills from working in a team environment is also vital within the ro
le.
Experience/Qualificati
- ons:Educated to BSc or above within Computer Science, Mathematics, or a Science related discipl
- ine.SAS Programming experience within the pharmaceutical indus
- try.Good awareness of clinical trial issues, design, and implementat
- ion.Experience of regulatory submissions and associated industry guida
- nce.Familiarity with GCP and regulatory requireme
- nts.Knowledge of SDTM and ADaM CDISC standa
rds.
Responsibili
- ties:Program and validate datasets and SDTMs, including complex efficacy, labs,
- etc.Become an independent technical ex
- pert.Program complex non efficacy outputs/fig
- ures.Perform Senior review and deliver QC of non- statistical ou
- tput.Become involved in developing the standard macro library and take responsibility to implement standard macros within a s
- tudy.Validate and perform User Acceptance Testing (UAT) on standard ma
- cros.Identify macros requirements, communicate and perform trai
- ning.Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs,
- etc.Implement and coordinate development and maintenance of MAC standard specificat
- ions.Be an SDTM and ADAM expert providing consultancy, advice and trai
- ning.Be aware of up and coming changes to CRT and define XML standards and regulatory guidelines and requirem
- ents.Implement and coordinate the development and maintenance of MAC CRT t
- ools.Become familiar with and follow study documenta
- tion.Initiating projects and ideas for furthering programming develop
- ment.Ensure the principles in the MAC checklist are followed rigoro
- usly.Develop archiving systems and proce
- sses.Act as a lead programmer on multiple studies and projects, ensuring quality and timely deli
- very.Liaise with Study Statistician and Project Manager regarding resourcing and delivera
- bles.Responsible for study level resou
- rces.Provide mentoring and training to junior team mem
- bers.Attend and input to company resourcing mee
- ting.Point of contact for programming issues for the team, proactively ensuring everything is working cohesi
- vely.Persuade stakeholders to follow best practice within a t
- rial.Develop and deliver company-wide training as and when requ
- ired.Identify areas where new processes are requ
- ired.Create, review and update processes and
- SOPs.Take responsibility for study compliance with SOPs and proce
sses.
This position is remote (although can be office based or hybrid, depending on your location) and will involve occasional travel to events throughout the
year.If your preference is home based, we would require you to have a set up at home that allows you to work comfortably. This includes an appropriate desk and chair (excl. IT equipment which we will provide). By proceeding with your application, you are confirming you are able to do
this.
BE
- NEFITS:Health In
- suranceFree onsite
- parking25 days annual leave (increasing in increments to 30 days after 6 years' s
- ervice)Your birthday o
ff work
MAC Clinical Research invites applications from highly motivated candidates, with a desire to fulfil their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspi
rations.