MSD Malaysia
Associate Principal Statistical Programmer - Oncology (Hybrid)
MSD Malaysia, Rahway, New Jersey, us, 07065
Associate Principal Statistical Programmer - Oncology (Hybrid)Job Description
Position Description:
In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our Company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.
This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders. The Associate Principal Programmer will gather and interpret user requirements for analysis and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data into analysis/modeling datasets, and develop tables and figures according to statistical/modeling analysis plan.
This position will partner with stakeholders to solve problems; reduce the amount of programming task being completed by stakeholders to facilitate an increase in efficiency and compliance for statistical/modeling analyses. The Associate Principal Programmer will write programs to analyze data with statistical methods which are not currently available through commercial software packages. The incumbent will be a key collaborator with statisticians, modelers, and colleagues in other related function areas.
Primary Activities :
Lead programming deliverables for multiple studies
Provide technical consultation and analytical support to statisticians for exploratory and unplanned statistical analyses
Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and associated documentation
Ensure programmatic traceability from data source to analysis/modeling result
Maintain and manage a project plan including resource forecasting
Support the development of programming standards to enable efficient and high-quality production of programming deliverables
Represent statistical programming on process improvement activities
Enforce the compliance with SOPs in all the deliverables
Identify opportunities and develop tools to improve team efficiency
Position Qualifications :
Education Minimum Requirement:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS/R programming experience in a clinical trial environment
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS/R programming experience in a clinical trial environment
Required Experience and Skills:
Excellent interpersonal skills and ability to negotiate and collaborate effectively
Excellent written, oral, and presentation skills
Broad knowledge and significant experience in developing analysis and reporting deliverables for clinical trial projects (data, analyses, tables, graphics, listings)
Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders
Position Specific Required Skills and Experience:
Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH
Designs and develops complex programming algorithms
Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packages.
Experience in CDISC SDTM and ADaM standards
Thrives in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes
Efficiently manipulates very large databases including complex data preprocessing, filtering, and manipulation;
Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters).
Preferred Skills and Experience:
Familiarity with oncology concepts
Experience with at least one other software than SAS (e.g., R, Splus)
Good working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
Utilizes and contributes to the development of standard departmental SAS macros
Ability and interest to work across cultures and geographies
Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
Experience providing technical and/or programming guidance and mentoring to colleagues
Experience in process improvement
Active in professional societies
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.
Learn more about your rights, including under California, Colorado and other US State Acts.
Expected US salary range:
$135,500.00 - $213,400.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
#J-18808-Ljbffr
Position Description:
In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our Company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.
This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders. The Associate Principal Programmer will gather and interpret user requirements for analysis and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data into analysis/modeling datasets, and develop tables and figures according to statistical/modeling analysis plan.
This position will partner with stakeholders to solve problems; reduce the amount of programming task being completed by stakeholders to facilitate an increase in efficiency and compliance for statistical/modeling analyses. The Associate Principal Programmer will write programs to analyze data with statistical methods which are not currently available through commercial software packages. The incumbent will be a key collaborator with statisticians, modelers, and colleagues in other related function areas.
Primary Activities :
Lead programming deliverables for multiple studies
Provide technical consultation and analytical support to statisticians for exploratory and unplanned statistical analyses
Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and associated documentation
Ensure programmatic traceability from data source to analysis/modeling result
Maintain and manage a project plan including resource forecasting
Support the development of programming standards to enable efficient and high-quality production of programming deliverables
Represent statistical programming on process improvement activities
Enforce the compliance with SOPs in all the deliverables
Identify opportunities and develop tools to improve team efficiency
Position Qualifications :
Education Minimum Requirement:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS/R programming experience in a clinical trial environment
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS/R programming experience in a clinical trial environment
Required Experience and Skills:
Excellent interpersonal skills and ability to negotiate and collaborate effectively
Excellent written, oral, and presentation skills
Broad knowledge and significant experience in developing analysis and reporting deliverables for clinical trial projects (data, analyses, tables, graphics, listings)
Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders
Position Specific Required Skills and Experience:
Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH
Designs and develops complex programming algorithms
Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packages.
Experience in CDISC SDTM and ADaM standards
Thrives in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes
Efficiently manipulates very large databases including complex data preprocessing, filtering, and manipulation;
Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters).
Preferred Skills and Experience:
Familiarity with oncology concepts
Experience with at least one other software than SAS (e.g., R, Splus)
Good working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
Utilizes and contributes to the development of standard departmental SAS macros
Ability and interest to work across cultures and geographies
Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
Experience providing technical and/or programming guidance and mentoring to colleagues
Experience in process improvement
Active in professional societies
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.
Learn more about your rights, including under California, Colorado and other US State Acts.
Expected US salary range:
$135,500.00 - $213,400.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
#J-18808-Ljbffr