高级主管科学家，统计编程
Associate Principal Scientist, Statistical Programming
**职位描述**
**职责：**
- 支持多个和/或后期阶段的药物/疫苗临床开发项目的统计编程工作。
- 开发并执行统计分析和报告交付物（例如，安全性与有效性分析数据集、表格、清单、图表），其范围从单个临床试验到全球监管申请提交和上市后支持。
- 负责设计和维护支持多个利益相关方的统计数据集，包括临床开发、结果研究和安全性评估。
- 与统计和其他项目利益相关方合作，确保项目计划高效执行，并按时交付高质量成果。
- 在整个项目生命周期中担任统计编程的联系人和知识持有者。
- 利用全球和TA标准分析和报告编程开发与验证，并遵循部门SOP和良好编程实践。
- 维护和管理项目计划，包括资源预测。
- 协调包括外包供应商员工在内的全球编程团队的工作。
- 作为部门战略倡议小组的成员。
- 需要10%的国内差旅。
- 全职远程办公。
**要求：**
计算机科学、统计学、应用数学、生命科学、工程、制药或相关领域的学士学位或同等学历，并在该职位或相关岗位有9年经验；或上述领域的硕士学位或同等学历，并在该职位或相关岗位有7年经验。
需要满足以下所有条件的7年经验：
- SAS和临床试验编程，包括数据步骤、过程、SAS/MACRO、SAS/GRAPH；
- 领导大型和/或复杂的统计编程项目，包括协调编程团队的工作；
- 设计和开发复杂的编程算法；
- 临床数据管理概念以及与数据管理系统和流程协作的方式；
- CDISC和ADaM标准；
- 确保交付物质量和流程合规性；
- 将策略转化为战术活动；
- 预见利益相关方的需求；
- 在领导层具备美国和/或全球药物或疫苗监管申请提交经验，包括电子提交交付物的开发；
查看英文原文
**Job Description**
**DUTIES:**
- Support statistical programming activities for multiple and/or late-stage drug/vaccine clinical development projects.
- Develop and execute statistical analysis and report 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.
- Responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research, and safety evaluation.
- Collaborate with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables.
- Serve as the statistical programming point of contact and knowledge holder through the entire project life cycle.
- Analyze and report programming development and validation utilizing global and TA 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 outsourced provider staff.
- Be a member of departmental strategic initiative teams.
- 10% domestic travel required.
- Full-time telecommuting.
**REQUIREMENTS:**
Bachelor’s degree or equivalent in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Pharmaceuticals, or a closely related field and 9 years of experience in the position offered or a related role; or a Master’s degree or equivalent in the aforementioned fields and 7 years of experience in the position offered or a related role.
Requires 7 years of experience in all of the following:
- SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH;
- leading large and/or complex statistical programming projects that include coordinating the activities of a programming team;
- designing and developing complex programming algorithms;
- clinical data management concepts and ways of working with data management systems and processes;
- CDISC and ADaM standards;
- assuring deliverable quality and process compliance;
- turning strategy into tactical activities;
- anticipating stakeholder requirements;
- U.S. and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables;
- comprehending analysis plans which may describe methodology to be programmed;
- statistical terminology, models, and concepts;
- and designing statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices.
The salary range for this role is: **$145,475.00 - $224,100.00 per year**
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
**Required Skills:**
**Preferred Skills:**
Current Employees apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
**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](https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
[Learn more about your rights, including under California, Colorado and other US State Acts](https://www.msdprivacy.com/us/en/CCPA-notice/)
The salary range for this role is
$142,400.00 - $224,100.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at [https://jobs.merck.com/us/en/compensation-and-benefits](https://jobs.merck.com/us/en/compensation-and-benefits).
You can apply for this role through [https://jobs.merck.com/us/en](https://jobs.merck.com/us/en) (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
**Search 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:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
10%
**Flexible Work Arrangements:**
Not Applicable
**Shift:**
Not Indicated
**Valid Driving License:**
No
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
12/7/2026
***A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.**