Job Title:Associate Principal Scientist, Statistical Programmer Oncology (Remote) Location:All Cities,
Company:Merck Industry Sector:Agribusiness Salary:Competetive Job Description:Job Description
Our Quantitative Sciences team uses 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.
The Associate Principal Scientist, Statistical Programming-Oncology leads the statistical programming activities for multiple and/or large/complex 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. Key areas of focus include: (1) the assurance of deliverable quality and process compliance, (2) effective deliverable development utilizing global and therapeutic area (TA) standards that optimize analysis and reporting and promote a strategic knowledge-base data model, (3) maintaining and managing a project plan including resource forecasting, (4) coordinating the activities of a global programming team that includes outsource provider staff, and (5) membership on departmental strategic initiative project teams such as new statistical computing platform evaluation and development.
Design and maintenance of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation
Key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables
Serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle for assigned projects
Minimum required education:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9-12 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
RequiredExperience and Skills:
Directing large and/or complex statistical programming projects that include coordinating the activities of a programming team
Expansive knowledge and significant experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements
Expertise in SAS and clinical trial programming including data steps, procedures, MACRO, SAS/GRAPH; systems and database expertise | Familiarity with statistical analysis methods and clinical data management concepts
United States and/or worldwide drug or vaccine regulatory application submission knowledge at the leadership level including the development of electronic submission deliverables.
Strategic, effective and strong project management skills
Program Leader who establishes appropriate programming methodology, assures programming consistency across protocols and projects, completes programming tasks, and directs the program development effort of other programmers; an experienced programming mentor; ability to engage key stakeholders
Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed
Comprehension of statistical terminology and concepts Designs and develops complex programming algorithms
Principled and effective communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders
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
CDISC and ADaM standards skills
Demonstrated success in the assurance of deliverable quality and process compliance
Ability to anticipate stakeholder and regulatory requirements
Preferred Experience and Skills:
Strong working knowledge of reporting processes, standard operating procedures (SOPs) and software development life-cycle (SDLC)
Ability and interest to work across cultures and geographies
Providing technical and/or programming guidance and mentoring to colleagues
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
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.
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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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We 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.
Under New York City 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: $117,600.00 - $200,100.00
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
VISA Sponsorship: Yes
Travel Requirements: No Travel Required
Flexible Work Arrangements: Flex Time, Work Week
Valid Driving License:
Number of Openings: 1
To apply please click on APPLY TO THIS POSITION
Job Post Date: 11/03/22
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