Associate Principal Programmer, Statistical Programming Job

Employer
Location
Gwynedd, PA, US
Posted
March 16 2017
Discipline
Other
Organization Type
Pharma
Associate Principal Programmer, Statistical Programming-STA000833

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


Description:

This position reports to the Director, Statistical Programming (SP), within the Biostatistics and Research Decision Sciences (BARDS) organization and is a member of the Global Process, Portfolio and Platform Standards (GP3S) team supporting SP personnel to ensure they have the processes, systems, tools, training and information they need to operate effectively. As a member of the GP3S Team, this position contributes to the Statistical Programming department and the overall Quantitative Sciences organization in various ways.

The position serves as an owner/steward of many departmental procedures and systems used by staff to efficiently create quality, compliant analysis and reporting and submission deliverables.

Key areas of focus include:

- Analysis and Reporting processes/procedures and corresponding training.

- Statistical analysis and reporting platforms and medical monitoring utilities.

- Submission standards processes and tools including SDTM up-versioning, case report tabulations, OSI and ICH listings as well as submission data review guidelines (SDRG) and analysis data review guidelines (ADRG).

- Development and support of the departmental project and resource portfolio system.

- Engagement with operational staff and partners globally.

- Driving compliance initiatives and serving as leader/member of strategic and cross-departmental teams.

Qualifications

Education Minimum Requirement:

- BA/BS in Computer Science, Statistics, Life Sciences or related field, Preferred: MS or PhD.

Required Experience and Skills:

- With a BA/BS, 9 to 12 years’ experience in Statistics, Software Development, Clinical Data Management, Clinical Research, or Database Design & Development.

- With an MS, a minimum of (5) years’ experience in Statistics, Software Development, Clinical Data Management, Clinical Research, or Database Design & Development.

- Strong project management skills with the ability to lead at a program level, determine an approach, ensure consistency and direct the development effort of others when opportunities arise.

- Ability to organize and manage work to complete tasks independently.

- Demonstrated interpersonal skills and ability to communicate effectively with excellent written, oral, and presentation communication skills.

- Excellent interpersonal skills and ability to negotiate and collaborate effectively; Ability to engage key stakeholders.

- Broad knowledge in statistical programming and developing Analysis and Reporting deliverables for research and development projects (datasets, analyses, tables, graphics, listings).

- Good working knowledge of reporting systems and standard report capabilities using SAS programming. Demonstrated experience in complex data reporting in a statistical environment.

- Broad knowledge of clinical trials processes, data structures and corresponding tools used to manage, extract, analyze & report data.

- Comprehensive knowledge of operating procedures, regulatory requirements (e.g. 21 CFR Part 11) and software development life-cycle (SDLC).

- Thorough understanding of statistics, clinical, medical monitoring and data management concepts as applied to drug/vaccine development within Pharmaceutical industry.  

Preferred Experience and Skills:

- Six Sigma and/or Process Improvement Certification.

- Experience with MS Visio and MS Project.

- J-Review/I-Review knowledge.

- Experience with developing training content including videos.

- Website management.

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

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

EEOC Poster

EEOC GINA Supplement​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Statistical Programming

Job Title:Assoc Prin.Scientist Stat.Programming

Primary Location: NA-US-PA-Upper Gwynedd

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 5 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck

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