Associate Principal Statistical Programmer - Oncology

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Job Title: Associate Principal Statistical Programmer - Oncology
Location: New York, NY, Mid-Atlantic United States,

Company: Merck
Industry Sector: Agribusiness

Job Description: 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.

This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders. The Associate Principal Programmer will gather and interpret user requirements for analysis and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data into analysis/modeling datasets, and develop tables and figures according to statistical/modeling analysis plan. This position will partner with stakeholders to solve problems; reduce the amount of programming task being completed by stakeholders to facilitate an increase in efficiency and compliance for statistical/modeling analyses. The Associate Principal Programmer will write programs to analyze data with statistical methods which are not currently available through commercial software packages. The incumbent will be a key collaborator with statisticians, modelers, and colleagues in other related function areas.

Primary Activities :

Lead programming deliverables for multiple studies
Provide technical consultation and analytical support to statisticians for exploratory and unplanned statistical analyses
Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and associated documentation
Ensure programmatic traceability from data source to analysis/modeling result
Maintain and manage a project plan including resource forecasting
Support the development of programming standards to enable efficient and high-quality production of programming deliverables
Represent statistical programming on process improvement activities
Enforce the compliance with SOPs in all the deliverables
Identify opportunities and develop tools to improve team efficiency

Educational Qualifications :

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9-12 years SAS/R 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/R 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 clinical trial 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
Designs and develops complex programming algorithms
Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packages.
Experience in CDISC SDTM and ADaM standards
Thrives in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes
Efficiently manipulates very large databases including complex data preprocessing, filtering, and manipulation;
Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters).

Preferred Skills and Experience:

Familiarity with oncology, clinical pharmacology concepts and pharmacokinetics concepts
Experience with at least one other software than SAS (e.g., R, Splus)
Good working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
Utilizes and contributes to the development of standard departmental SAS macros
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 providing technical and/or programming guidance and mentoring to colleagues
Experience in process improvement
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.

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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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.

For more information about personal rights under Equal Employment Opportunity, visit:

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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, 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:
$130,960.00 - $206,200.00
For Washington State Jobs, a summary of benefits is listed here .

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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:
Domestic

VISA Sponsorship:
Yes

Travel Requirements:

Flexible Work Arrangements:
Flex Time, Hybrid, On-Site

Shift:
1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:
1

To apply please click on APPLY TO THIS POSITION

Job Post Date: 01/12/23