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Regulatory affairs Jobs in Sudbury, ON

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Regulatory affairs • sudbury on

Last updated: 3 hours ago
Principal r Programmer- Pk / pd Experience Required

Principal r Programmer- Pk / pd Experience Required

Syneos HealthOntario, Canada
Full-time
Principal Statistical Programmer.Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical aff...Show moreLast updated: 30+ days ago
  • Promoted
Director of Fire Protection Engineering

Director of Fire Protection Engineering

Ignis Global RecruitmentGreater Sudbury, ON, Canada
Full-time
We're seeking a Director of Fire Protection Engineering to spearhead technical leadership and strategic direction in fire protection engineering. As a Director of Fire Protection Engineering, yo...Show moreLast updated: 30+ days ago
Scarborough Health Network Chief Technology Officer

Scarborough Health Network Chief Technology Officer

BoydenON, CA
Permanent
Scarborough Health Network (SHN) is shaping the future of care, designing a more integrated healthcare system for one of Canada’s most diverse communities. For more than 850,000 people throughout th...Show moreLast updated: 30+ days ago
  • Promoted
Senior Accountant, SEC Reporting and Technical Accounting

Senior Accountant, SEC Reporting and Technical Accounting

RivianChelmsford, ON, Canada
Full-time
Rivian is on a mission to keep the world adventurous forever.This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract.As a company...Show moreLast updated: 30+ days ago
  • Promoted
Biostatistics Leader - CVRM

Biostatistics Leader - CVRM

Roche Holdings Inc.Chelmsford, ON, Canada
Full-time
We advance science so that we all have more time with the people we love.As the Biostatistics Leader - Cardiovascular, Renal, and Metabolic (CVRM), you will provide strategic leadership and oversig...Show moreLast updated: 30+ days ago
  • Promoted
Assistant Professor - Information Security

Assistant Professor - Information Security

InsideHigherEdGreater Sudbury, Ontario, Canada
Full-time +1
Assistant Professor - Information Security.Faculty - Tenure Stream (continuing).Munk School of Global Affairs and Public Policy. THIS POSTING HAS BEEN EXTENDED TO THE NEW CLOSING DATE OF MONDAY JANU...Show moreLast updated: 30+ days ago
  • Promoted
Vice President of Research Administration

Vice President of Research Administration

The Jackson LaboratoryLively, ON, Canada
Full-time
Vice President of Research Administration.Bar Harbor, ME ; Portland, ME; or Farmington, CT.Please submit a cover letter and CV. Applications without a cover letter will not be considered.The Vice Pr...Show moreLast updated: 1 day ago
Director / Consultant, Regulatory Affairs

Director / Consultant, Regulatory Affairs

Innomar StrategiesRemote, ON
Remote
Full-time
Our team members are at the heart of everything we do.At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on ...Show moreLast updated: 30+ days ago
  • Promoted
Environmental Engineer

Environmental Engineer

BESTECHSudbury, ON, Canada
Full-time +1
Salary : Based on experience level.BESTECH is an innovative multi-disciplinary engineering services firm with over 25 years of proven success across many engineering disciplines.Operating at over 10...Show moreLast updated: 30+ days ago
  • Promoted
Facilities Manager

Facilities Manager

PENN EntertainmentGreater Sudbury, ON, Canada
Full-time
We’re always looking for talent that believes in having fun.At PENN Entertainment, you’ll get to be a part of an exciting industry, where the days and nights are fast-paced.You’ll work with an incr...Show moreLast updated: 30+ days ago
  • Promoted
  • New!
Senior Land Manager

Senior Land Manager

CQ Search Group Ltd.sudbury, ON, Canada
Full-time
Our client, a global mining company in Canada is seeking a Senior Land Manager.Maintain and improve upon a robust Property Management System that will ensure all properties in Canada are maintained...Show moreLast updated: 3 hours ago
  • Promoted
Sr. Lab Analyst, LC-MS / MS Operator

Sr. Lab Analyst, LC-MS / MS Operator

Pharma Medica Research Inc.Ontario, ON, Canada
Full-time
Pharma Medica Research is a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations.We are currently...Show moreLast updated: 30+ days ago
  • Promoted
Senior Operations Manager / Chief Operating Officer (COO)

Senior Operations Manager / Chief Operating Officer (COO)

moomooOntario, ON, Canada
Full-time
About Moomoo Canada Financial Inc.MFC) is a subsidiary of FUTU Holdings Inc.NASDAQ : FUTU), a global leader in online brokerage and wealth management solutions. Moomoo is one of the most trusted and ...Show moreLast updated: 30+ days ago
Remote Customer Success Manager – Tadaweb

Remote Customer Success Manager – Tadaweb

JobspaddyOntario
Remote
Full-time
Tadaweb is a scale-up technology company providing an open-source information platform that magnifies the impact of investigative, analytical and operations teams. Over the past 11 years, Tadaweb ha...Show moreLast updated: 30+ days ago
Utility Gang

Utility Gang

Genesee & Wyoming MainSudbury, Ontario, Canada
Full-time
The Utility Gang employee works as a crewmember to repair and replace rails ties plates switches and ballast.The selected candidate will perform the following functions : . Perform the duties involved...Show moreLast updated: 29 days ago
  • Promoted
Compliance Paralegal

Compliance Paralegal

IntelliPro Group Inc.Ontario, ON, Canada
Full-time
We are seeking a detail-oriented and highly organized.The ideal candidate has a strong understanding of regulatory frameworks relevant to our industry, excellent communication and research skills, ...Show moreLast updated: 30+ days ago
  • Promoted
Medical Laboratory Technologist (MLT)

Medical Laboratory Technologist (MLT)

SpeedStaff MedicalGreater Sudbury, ON, Canada
Full-time
Medical Laboratory Technologist.Medical Laboratory Technologist.This role provides the opportunity to work across multiple laboratory disciplines, engaging both directly with patients and in behind...Show moreLast updated: 24 days ago
  • Promoted
Environmental Geochemist

Environmental Geochemist

Klohn Crippen BergerSudbury, ON, Canada
Full-time
Posted Monday, April 15, 2024 at 7 : 00 AM.Are you looking for an opportunity to….Leave a positive impact on the environment through progressive design?. Work in a close-knit group of motivated profes...Show moreLast updated: 30+ days ago
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Principal r Programmer- Pk / pd Experience Required

Principal r Programmer- Pk / pd Experience Required

Syneos HealthOntario, Canada
30+ days ago
Job type
  • Full-time
Job description

Description

Principal Statistical Programmer

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job responsibilities

  • Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
  • Works to ensure that outputs meet quality standards and project requirements.
  • Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings.
  • Keeps project team members informed of programming progress and issues requiring their attention.
  • Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
  • Maintains well organized, complete, and up-to-date project documentation, testing, and verification / quality control documents and programs ensuring inspection readiness.
  • Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
  • Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor / requestor with little rework.
  • Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.
  • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
  • Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions.
  • Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables.
  • Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
  • Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
  • Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.
  • Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions.
  • Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and / or procedures.
  • Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.
  • When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards
  • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML)
  • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards.
  • Transfers deliverables.
  • Performs other work-related duties as assigned.
  • Minimal travel may be required
  • Qualifications

    What we're looking for

  • Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.
  • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and / or global projects with teams of statistical programmers.
  • Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred.
  • Experience in mentoring others in clinical trial process and CDISC Standards.
  • Excellent written and verbal communication skills.
  • Ability to read, write, speak and understand English.
  • Get to know Syneos Health

    Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

    No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

    Additional Information :

    Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.