Job Description

Position Overview: 


As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote.


Our values


We believe in applying scientific rigor to reveal the full promise inherent in data.
We... nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
We prize innovation and seek intelligent solutions using leading-edge technology.


Responsibilities

How you will contribute:


Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
Production and QC / validation programming
Generating complex ad-hoc reports utilizing raw data
Applying strong understanding/experience of Efficacy analysis
Creating and reviewing submission documents and eCRTs
Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
Performing lead duties when called upon
Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
Being adaptable and flexible when priorities change


Qualifications


Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:    
Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above.
Study lead experience, preferably juggling multiple projects simultaneously preferred.
Strong SAS data manipulation, analysis and reporting skills.
Solid experience implementing the latest CDISC SDTM / ADaM standards.
Strong QC / validation skills.
Good ad-hoc reporting skills.  
Proficiency in Efficacy analysis.
Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
Submissions experience utilizing define.xml and other submission documents.
Experience supporting immunology, respiratory or oncology studies would be a plus.
Excellent analytical & troubleshooting skills.
Ability to provide quality output and deliverables, in adherence with challenging timelines.
Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners. more

You will contribute by:

Providing significant technical expertise for statistical programming in all phases of programming support, developing automated reports and preparation of submission data standard packages.
Supporting statistical programming activities for multiple and/or large/complex drug/vaccine clinical development projects.
Development and execution of statistical analysis and... reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures),
Design and maintenance of statistical datasets that support multiple stakeholder groups.
Serving as key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.
Being able to serve as statistical programming point of contact and knowledge holder through the entire product lifecycle for the assigned protocol if/when called upon.
Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.
Maintaining and managing a project plan including resource forecasting.
Coordinating the activities of the supplier’s programming team; and interacting with client statistical programmers
Utilizing strong project management skills and ability to engage key stakeholders; leadership at a protocol level; determining approach and ensuring consistency, and directing development of others when opportunities arise.
Designing and developing complex programming algorithms.
Comprehending analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts.
Utilizing expertise in CDISC and ADaM standards.  
Statistical programming for early and late stage clinical trials which can include both planned and ad-hoc needs.   
Enriched / Post Processed Datasets (individual or integrated).
ADaM datasets (individual or integrated)
Protocol and therapeutic area specific tables, listings, and figures (individual or integrated).
Programming documentation following SOPs .

What you offer:

Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
Minimum 10 years of SAS programming experience supporting clinical trials in the Pharmaceutical & Biotech industry.   
5+ years of study lead experience working with cross functional teams, including leading programming teams.    
Minimum 3 years of recent experience supporting Oncology studies.    
Strong experience in QCing and validating work of other programmers, preferably outsourced work.  
Strong SAS data manipulation, analysis and reporting skills- with strong output programming experience  
Strong proficiency implementing the latest CDISC SDTM / ADaM standards.   
Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.  
Submissions experience utilizing define.xml and other submission documents.
Excellent analytical & troubleshooting skills.
Ability to provide quality output and deliverables, in adherence with challenging timelines.
Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners. more