Principal Biostatistician / no-113

Location
CH-Basel
Start
asap
End
31.07.2022
Workload
100 %
All-in / Hour
rate: see job description
Total Hours
1120

Deadline:

Deadline
01.12.2021

 

Principal Biostatistician / no-113

Location
CH-Basel
Workload
100 %

Start

asap

End

31.07.2022

DEADLINE

Deadline
01.12.2021

  • CH-Basel
  • CH-Baselasap31.07.2022100 % 1120rate: see job descriptionDeadline
    01.12.2021

For our customer located in Basel/Switzerland we are currently looking for a

Principal Biostatistician (m/f/x)

 

Hourly Gross Rate Range (given by client): 55,70 – 62,70 chf/h gross

Monthly Workload: 100% (160h/month)

 

Background: 

 

The Principal Biostatistician is responsible for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. May support project level deliverables for a development project with supervision.
Leads implementation of modern and innovative clinical trial/experimental designs, statistical models, analyses and data exploration at the study level.

Tasks & Responsibilities

Study Level:

  • Responsible for all statistical tasks on assigned trials, and perform these tasks independently seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician.
  • Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required.
  • Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate. Represent our client in statistical discussions at external congresses, conferences, scientific meetings.
  • Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness of status and issues related to the as-signed trials.
  • Collaborate with other line functions. Explain statistical concepts in manner easily understood by non-statisticians and provide adequate statistical justifications for actions/decisions/statements as required.
  • Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team.
  • Oversee all Biostatistics resources and deliverables for assigned trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities.

 

Project Level:

  • Contribute to project level activities as needed.
  • Contributes to project team preparation for HA Advisory Committees and meetings.

Franchise or Global Line Function Level

  • Contribute to initiatives at global line function level

 

Enterprise Level:

  • Participate in non-clinical project activities as needed
  • Contribute to the review and implementation of health authority guidances
  • Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer re-viewed journals and presentations at professional meetings

 

External Level:

  • Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate.
  • Represent our client in statistical discussions at external congresses, conferences, scientific meetings.

 

People Management:

  • Mentor new hires and/or junior Statisticians

Must Haves

  • MS (in Statistics or equivalent) with 4+ years relevant work experience or PhD (in Statistics or equivalent) with relevant work experience (including internship)
  • Fluent English (oral and written); Good communication and presentation skills.
  • Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives.
  • Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. 
  • Proficiency in use of statistical software packages (e.g. SAS, R). Knowledge of drug development and Health Authority guidelines. Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives.
  • Experience in Franchise/Therapeutic Area and/or regulatory activities desirable.

Did we catch your interest? 

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.

Tagged as: Clinical Trial, pharmacokinetics

Files must be less than 5 MB.
Allowed file types: txt rtf pdf doc docx.
If not - no problem - we'll organize one.
More optional Information about your way of finding us
You agree that your data will be used to process your request. Further information and revocation instructions can be found in the privacy policy.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.

  • CH-Basel
  • CH-Baselasap31.07.2022100 % 1120rate: see job descriptionDeadline
    01.12.2021

For our customer located in Basel/Switzerland we are currently looking for a

Principal Biostatistician (m/f/x)

 

Hourly Gross Rate Range (given by client): 55,70 – 62,70 chf/h gross

Monthly Workload: 100% (160h/month)

 

Background: 

 

The Principal Biostatistician is responsible for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. May support project level deliverables for a development project with supervision.
Leads implementation of modern and innovative clinical trial/experimental designs, statistical models, analyses and data exploration at the study level.

Tasks & Responsibilities

Study Level:

  • Responsible for all statistical tasks on assigned trials, and perform these tasks independently seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician.
  • Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required.
  • Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate. Represent our client in statistical discussions at external congresses, conferences, scientific meetings.
  • Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness of status and issues related to the as-signed trials.
  • Collaborate with other line functions. Explain statistical concepts in manner easily understood by non-statisticians and provide adequate statistical justifications for actions/decisions/statements as required.
  • Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team.
  • Oversee all Biostatistics resources and deliverables for assigned trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities.

 

Project Level:

  • Contribute to project level activities as needed.
  • Contributes to project team preparation for HA Advisory Committees and meetings.

Franchise or Global Line Function Level

  • Contribute to initiatives at global line function level

 

Enterprise Level:

  • Participate in non-clinical project activities as needed
  • Contribute to the review and implementation of health authority guidances
  • Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer re-viewed journals and presentations at professional meetings

 

External Level:

  • Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate.
  • Represent our client in statistical discussions at external congresses, conferences, scientific meetings.

 

People Management:

  • Mentor new hires and/or junior Statisticians

Must Haves

  • MS (in Statistics or equivalent) with 4+ years relevant work experience or PhD (in Statistics or equivalent) with relevant work experience (including internship)
  • Fluent English (oral and written); Good communication and presentation skills.
  • Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives.
  • Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. 
  • Proficiency in use of statistical software packages (e.g. SAS, R). Knowledge of drug development and Health Authority guidelines. Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives.
  • Experience in Franchise/Therapeutic Area and/or regulatory activities desirable.

Did we catch your interest? 

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.

Tagged as: Clinical Trial, pharmacokinetics

Files must be less than 5 MB.
Allowed file types: txt rtf pdf doc docx.
If not - no problem - we'll organize one.
More optional Information about your way of finding us
You agree that your data will be used to process your request. Further information and revocation instructions can be found in the privacy policy.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.

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