Job DescriptionDUTIES:- 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 yearThis 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
Current Contingent Workers apply HERE
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.
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. 
