Pharmaron
Position:
Principal Statistician
FLSA Status:
Exempt
Location:
Onsite (Somerset, NJ)
Salary:
$110,000 to $135,000 per year
Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.
We're proud of the impact we make and just last year, we supported over
780 discovery projects ,
1,000+ CMC programmes , and
1,000+ clinical trials
across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than
3,000 global customers . To learn more, visit www.pharmaron.com.
Job Overview
Develop and/or review statistical sections of a study protocol with high complexity independently.
Perform and/or verify sample size and statistical power calculation for typical trial designs.
Develop statistical analysis plans, table/listings/figures mock-ups and statistical analysis reports for a study with different complexity.
Act as a randomization statistician to develop the randomization protocol and generate the randomization schedule.
Attend client meetings including, but not limited to, project kick‑off meetings, resource/timelines discussions, bid defenses, blind data review meetings etc.
QC/review case report form and other DM documents including, but not limited to edit check specifications, data review plan, data transfer specification and etc.
QC/review programming deliverables including, but not limited to programming specifications, analysis datasets and TLFs etc. to ensure meet the analysis requirements.
Mentor statistical programmers on understanding of statistical design, and the implementation of statistical models.
Mentor Biostatisticians with statistical relevant work.
Ensure all activities in accordance with internal and external quality standards, SOPs/WIs, ICH‑GCP and/or any other applicable local and international regulations, guidelines and industry standards.
What We're Looking For
Master degree or above in biostatistics, statistics, mathematics, or relevant scientific disciplines preferred, or Bachelor degree with an equivalent amount of experience can be substitute as appropriate.
5+ years relevant experience in clinical trial statistics.
Familiar with SAS Base, SAS/Macros, SAS/Graph, SAS/Stat and reporting process.
Familiar with CDISC CDASH/SDTM/ADaM standards.
Compliance in SOPs/WIs, ICH‑GCP and any other applicable local and international regulations, guidelines and industry standards.
Why Pharmaron? Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.
Collaborative Culture You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.
Benefits
Insurance including Medical, Dental & Vision with significant employer contributions
Employer-funded Health Reimbursement Account
Healthcare & Dependent Care Flexible Spending Accounts
100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance
401k plan with generous employer match
Access to an Employee Assistance Program
How To Apply Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!
As an Equal Employment Opportunity and Affiliation Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
Salary: $110,000 - $135,000 per year
#J-18808-Ljbffr
Principal Statistician
FLSA Status:
Exempt
Location:
Onsite (Somerset, NJ)
Salary:
$110,000 to $135,000 per year
Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.
We're proud of the impact we make and just last year, we supported over
780 discovery projects ,
1,000+ CMC programmes , and
1,000+ clinical trials
across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than
3,000 global customers . To learn more, visit www.pharmaron.com.
Job Overview
Develop and/or review statistical sections of a study protocol with high complexity independently.
Perform and/or verify sample size and statistical power calculation for typical trial designs.
Develop statistical analysis plans, table/listings/figures mock-ups and statistical analysis reports for a study with different complexity.
Act as a randomization statistician to develop the randomization protocol and generate the randomization schedule.
Attend client meetings including, but not limited to, project kick‑off meetings, resource/timelines discussions, bid defenses, blind data review meetings etc.
QC/review case report form and other DM documents including, but not limited to edit check specifications, data review plan, data transfer specification and etc.
QC/review programming deliverables including, but not limited to programming specifications, analysis datasets and TLFs etc. to ensure meet the analysis requirements.
Mentor statistical programmers on understanding of statistical design, and the implementation of statistical models.
Mentor Biostatisticians with statistical relevant work.
Ensure all activities in accordance with internal and external quality standards, SOPs/WIs, ICH‑GCP and/or any other applicable local and international regulations, guidelines and industry standards.
What We're Looking For
Master degree or above in biostatistics, statistics, mathematics, or relevant scientific disciplines preferred, or Bachelor degree with an equivalent amount of experience can be substitute as appropriate.
5+ years relevant experience in clinical trial statistics.
Familiar with SAS Base, SAS/Macros, SAS/Graph, SAS/Stat and reporting process.
Familiar with CDISC CDASH/SDTM/ADaM standards.
Compliance in SOPs/WIs, ICH‑GCP and any other applicable local and international regulations, guidelines and industry standards.
Why Pharmaron? Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.
Collaborative Culture You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.
Benefits
Insurance including Medical, Dental & Vision with significant employer contributions
Employer-funded Health Reimbursement Account
Healthcare & Dependent Care Flexible Spending Accounts
100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance
401k plan with generous employer match
Access to an Employee Assistance Program
How To Apply Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!
As an Equal Employment Opportunity and Affiliation Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
Salary: $110,000 - $135,000 per year
#J-18808-Ljbffr