Senior Scientist, Statistical Programmer (Hybrid)
Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our 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.
Our Quantitative Sciences team use big data to analyze the safety and efficacy claims of our potential medical breakthroughs.
We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.
This position supports statistical programming activities for late stage drug/vaccine clinical development projects.
This may include leadership of one or more projects.
Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.
g.
safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.
The incumbant is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.
The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.
For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.
Primary Activities:
Effective study and report programming development and validation utilizing global and Therapeutic Areas standards and following departmental SOPs and good programming practices Maintain and manage a project plan including resource forecasting Coordinate the activities of a global programming team that includes outsource provider staff Education Minimum Requirement:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 5years SAS programming experience in a clinical trial environment MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 3 years SAS programming experience in a clinical trial environment Required Experience and Skills:
Effective interpersonal skills and ability to negotiate and collaborate effectively Effective written, oral, and presentation skills Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise Designs and develops complex programming algorithms Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards Experience ensuring process compliance and deliverable quality Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices Preferred Experience and Skills:
Demonstrated success in the assurance of deliverable quality and process compliance.
Strong working knowledge of reporting processes and software development life-cycle (SDLC) Familiarity of US and/or worldwide drug or vaccine regulatory application submission including the development of electronic submission deliverables Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers Ability and interest to work across cultures and geographies Ability to complete statistical programming deliverables through the use of global outsource partner programming staff Engagement within professional societies #EligibleforERPBARDS2020SPJOBSVETJOBS#EBRGWe are a research-driven biopharmaceutical company.
Our mission is built on the simple premise that if we follow the science and that great medicines can make a significant impact to our world.
And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERECurrent Contingent Workers apply HEREUS 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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work ModelEffective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job.
Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$107,600.
00 - $169,400.
00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
For Washington State Jobs, a summary of benefits is listed here.
Learn more about your rights, including under California, Colorado and other US State ActsSearch Firm Representatives Please Read Carefully Merck & Co.
, Inc.
, Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Where agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/a Recommended Skills Algorithms Big Data Claim Processing Clinical Data Management Clinical Development Clinical Trials Estimated Salary: $20 to $28 per hour based on qualifications.
Our Quantitative Sciences team use big data to analyze the safety and efficacy claims of our potential medical breakthroughs.
We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.
This position supports statistical programming activities for late stage drug/vaccine clinical development projects.
This may include leadership of one or more projects.
Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.
g.
safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.
The incumbant is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.
The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.
For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.
Primary Activities:
Effective study and report programming development and validation utilizing global and Therapeutic Areas standards and following departmental SOPs and good programming practices Maintain and manage a project plan including resource forecasting Coordinate the activities of a global programming team that includes outsource provider staff Education Minimum Requirement:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 5years SAS programming experience in a clinical trial environment MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 3 years SAS programming experience in a clinical trial environment Required Experience and Skills:
Effective interpersonal skills and ability to negotiate and collaborate effectively Effective written, oral, and presentation skills Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise Designs and develops complex programming algorithms Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards Experience ensuring process compliance and deliverable quality Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices Preferred Experience and Skills:
Demonstrated success in the assurance of deliverable quality and process compliance.
Strong working knowledge of reporting processes and software development life-cycle (SDLC) Familiarity of US and/or worldwide drug or vaccine regulatory application submission including the development of electronic submission deliverables Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers Ability and interest to work across cultures and geographies Ability to complete statistical programming deliverables through the use of global outsource partner programming staff Engagement within professional societies #EligibleforERPBARDS2020SPJOBSVETJOBS#EBRGWe are a research-driven biopharmaceutical company.
Our mission is built on the simple premise that if we follow the science and that great medicines can make a significant impact to our world.
And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERECurrent Contingent Workers apply HEREUS 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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work ModelEffective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job.
Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$107,600.
00 - $169,400.
00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
For Washington State Jobs, a summary of benefits is listed here.
Learn more about your rights, including under California, Colorado and other US State ActsSearch Firm Representatives Please Read Carefully Merck & Co.
, Inc.
, Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Where agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/a Recommended Skills Algorithms Big Data Claim Processing Clinical Data Management Clinical Development Clinical Trials Estimated Salary: $20 to $28 per hour based on qualifications.
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