Qureos Mentor

Cytel Inc

<div><div><div><div><b>Sponsor-dedicated:
</b></div><div></div><div>Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.<br>
</div><div></div><br>
<div><b>Position Overview:<br>
</b></div><div></div><br>
<div>As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM &amp; ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote.<br>
</div></div><div></div><br>
<div><div><b>Our values
</b></div><div><ul><li>We believe in applying scientific rigor to reveal the full promise inherent in data.
</li><li>We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
</li><li>We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
</li><li>We prize innovation and seek intelligent solutions using leading-edge technology.
</li></ul></div></div></div><div></div>
<div></div><div>ShortDescriptionStr</div>
<div>Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.</div>
<div></div>
<div><b>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:
</b><div><ul><li>Bachelor&rsquo;s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
</li><li>At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical &amp; Biotech industry with a bachelor&rsquo;s degree or equivalent. At least 6 years of related experience with a master&rsquo;s degree or above.
</li><li>Study lead experience, preferably juggling multiple projects simultaneously preferred.
</li><li>Strong SAS data manipulation, analysis and reporting skills.
</li><li>Solid experience implementing the latest CDISC SDTM / ADaM standards.
</li><li>Strong QC / validation skills.
</li><li>Good ad-hoc reporting skills.
</li><li>Proficiency in Efficacy analysis.
</li><li>Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials&rsquo; data.
</li><li>Submissions experience utilizing define.xml and other submission documents.
</li><li>Experience supporting immunology, respiratory or oncology studies would be a plus.
</li><li>Excellent analytical &amp; troubleshooting skills.
</li><li>Ability to provide quality output and deliverables, in adherence with challenging timelines.
</li><li>Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
</li></ul></div></div><div>InternalQualificationsStr</div>
<div><b>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:
</b><div><ul><li>Bachelor&rsquo;s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
</li><li>At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical &amp; Biotech industry with a bachelor&rsquo;s degree or equivalent. At least 6 years of related experience with a master&rsquo;s degree or above.
</li><li>Study lead experience, preferably juggling multiple projects simultaneously preferred.
</li><li>Strong SAS data manipulation, analysis and reporting skills.
</li><li>Solid experience implementing the latest CDISC SDTM / ADaM standards.
</li><li>Strong QC / validation skills.
</li><li>Good ad-hoc reporting skills.
</li><li>Proficiency in Efficacy analysis.
</li><li>Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials&rsquo; data.
</li><li>Submissions experience utilizing define.xml and other submission documents.
</li><li>Experience supporting immunology, respiratory or oncology studies would be a plus.
</li><li>Excellent analytical &amp; troubleshooting skills.
</li><li>Ability to provide quality output and deliverables, in adherence with challenging timelines.
</li><li>Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
</li></ul></div></div><div>InternalResponsibilitiesStr</div>
<div>
<p><b>How you will contribute:
</b></p><p></p><ul><li>Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
</li><li>Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
</li><li>Production and QC / validation programming
</li><li>Generating complex ad-hoc reports utilizing raw data
</li><li>Applying strong understanding/experience of Efficacy analysis
</li><li>Creating and reviewing submission documents and eCRTs
</li><li>Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
</li><li>Performing lead duties when called upon
</li><li>Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
</li><li>Being adaptable and flexible when priorities change
</li></ul></div><p></p><div>ExternalResponsibilitiesStr</div>
<div>
<p><b>How you will contribute:
</b></p><p></p><ul><li>Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
</li><li>Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
</li><li>Production and QC / validation programming
</li><li>Generating complex ad-hoc reports utilizing raw data
</li><li>Applying strong understanding/experience of Efficacy analysis
</li><li>Creating and reviewing submission documents and eCRTs
</li><li>Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
</li><li>Performing lead duties when called upon
</li><li>Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
</li><li>Being adaptable and flexible when priorities change</li></ul></div></div><p></p>

Senior Statistical Programmer FSP

<div><div><div><div><b>Sponsor-dedicated:<br>
</b></div><div></div><br>
<div>Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.<br>
</div><div></div><br>
<div><b>Position Overview:<br>
</b></div><div></div><br>
<div>This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.<br>
</div></div></div><div></div>
<div></div><div>ShortDescriptionStr</div>
<div>Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.</div>
<div></div>
<div><b>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:
</b><div><ul><li>At a minimum bachelor&rsquo;s degree in computer science, data science, mathematics, or statistics major preferred
</li><li>7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies
</li><li>Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
</li><li>Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
</li><li>Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
</li><li>Must be able to work independently
</li><li>Outstanding communication skills (written and verbal) and strong leadership skills
</li></ul><div><div><b>Preferred Qualifications (nice to have)
</b></div><div><ul><li>Prior work experience with pharmacokinetic data and the neuroscience field,
</li>proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)<br>
<li>
</li></ul></div></div></div></div><div></div><br>
<div>InternalQualificationsStr</div>
<div><b>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:
</b><div><ul><li>At a minimum bachelor&rsquo;s degree in computer science, data science, mathematics, or statistics major preferred
</li><li>7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies
</li><li>Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
</li><li>Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
</li><li>Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
</li><li>Must be able to work independently
</li><li>Outstanding communication skills (written and verbal) and strong leadership skills
</li></ul><div><div><b>Preferred Qualifications (nice to have)
</b></div><div><ul><li>Prior work experience with pharmacokinetic data and the neuroscience field,
</li>proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)<br>
<li>
</li></ul></div></div></div></div><div></div><br>
<div>InternalResponsibilitiesStr</div>
<div>
<p><b>As a Principal Statistical Programmer, your responsibilities will include:
</b></p><p></p><ul><li>Generate SDTM, ADaM specifications, datasets, reviewer&rsquo;s guide and define.xml files for multiple studies
</li><li>Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
</li><li>Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs&rsquo; needs
</li><li>Participate in overseeing CRO&rsquo;s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
</li><li>Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
</li><li>Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
</li><li>Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
</li><li>Participate in the development of CRFs, edit check specifications, and data validation plans
</li><li>Provide review and/or author data transfer specifications for external vendor data
</li><li>Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
</li><li>Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices
</li></ul></div><p></p><div>ExternalResponsibilitiesStr</div>
<div>
<p><b>As a Principal Statistical Programmer, your responsibilities will include:
</b></p><p></p><ul><li>Generate SDTM, ADaM specifications, datasets, reviewer&rsquo;s guide and define.xml files for multiple studies
</li><li>Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
</li><li>Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs&rsquo; needs
</li><li>Participate in overseeing CRO&rsquo;s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
</li><li>Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
</li><li>Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
</li><li>Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
</li><li>Participate in the development of CRFs, edit check specifications, and data validation plans
</li><li>Provide review and/or author data transfer specifications for external vendor data
</li><li>Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
</li><li>Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices</li></ul></div></div><p></p>

Principal Statistical Programmer FSP

Join Cytel Inc and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Cytel Inc

ABOUT_COMPANY

Senior Statistical Programmer FSP

Principal Statistical Programmer FSP