Job Description
In 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.
This position supports statistical programming activities for multiple and/or late stage drug/vaccine clinical development 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.
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The incumbent 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 analysis 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 outsource provider staff.
- Membership on departmental strategic initiative teams
Education and Minimum Requirement:
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS 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 programming experience in a clinical trial environment.
Department Required Skills and Experience:
- 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 R&D 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; systems and database expertise.
- Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team.
- US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.
- 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
- Demonstrated success in the assurance of deliverable quality and process compliance.
- 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.
- Ability to anticipate stakeholder requirements.
* Preferred Skills and Experience:
- Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC)
- Experience providing technical and/or programming guidance and mentoring to colleagues.
- 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 developing and managing a project plan using Microsoft Project or similar package.
- Active in professional societies
- Experience in process improvement.
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NOTICEFORINTERNALAPPLICANTS
In 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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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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. A summary of benefits is listed here.
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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:
Domestic
VISA Sponsorship:
Yes
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
02/28/2025
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.
Requisition ID:R306311