Job 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.
The Principal Statistical Programmer, Submission Data Standards Quality Management (SDS QM), focuses on strategic activities impacting world-wide regulatory application submissions of drug and vaccine clinical development projects to the direct benefit of clinical development project teams. The position is a key collaborator with internal and external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management, Clinical and other project stakeholders. Accountability predominantly includes submission data standards planning activities, coaching and consulting with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards including SDTM, ADaM, clinical site data for CDER inspection planning etc.
Primary Responsibilities:
- Address operational challenges that require strategic solutions resulting in improved regulatory submissions in both timeliness and quality
- PreNDA and PreBLA meeting preparation, study data standards plan, preparing questions for FDA e-data mailboxes (CBER/CDER), attendance at meetings with regulatory agencies (FDA, EMA, PMDA),
- Guiding project teams preparing submission deliverables including use of Pinnacle 21 Enterprise,
- Leadership in industry teams and conferences on best practices
- Leadership on departmental strategic initiative project teams
Education:
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 12-15 years SAS programming experience in a clinical trial environment
- MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 10 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
- Superior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
- Excellent project management skills; leadership across multiple and complex programs; determines approach and ensures consistency and directs effort others; ability to engage key stakeholders
Position Specific Skills and Experience:
- US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables
- Superior knowledge with submission standards CDISC (SDTM, ADaM), Define.XML, SDRG, ADRG
- Demonstrated success in the assurance of deliverable quality and process compliance.
- Excels in technical writing, able to convert complex ideas and information into simple readable form
- Familiarity with clinical data management concepts
- Strategic thinking - ability to analyze operational activities and challenges and develop and implement strategic solutions
- Ability to anticipate stakeholder requirements
Preferred Skills and Experience:
- Experience in process assessment, improvement and operational excellence methodologies
- Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
- Providing technical and/or programming guidance and mentoring to colleagues
- Deals well with change and seamlessly assimilates to new projects and stakeholders
- Ability and interest to work across cultures and geographies
- Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
- Developing and managing a project plan using Microsoft Project or similar package
- Active in professional societies
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We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. 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.
Who we are ...
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for ...
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
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 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.
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For positions located in the United States and Puerto Rico - Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) ("Customer-Facing Role") who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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Under New York City, 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:
$159,200.00 - $250,700.00
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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:
10%
Flexible Work Arrangements:
Flex Time, Remote Work, Telecommuting
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
Number of Openings:
1
Requisition ID:R223379