Associate Principal Scientist, Statistical Programming - SDTM Job

Gwynedd, PA, US
August 01 2017
Organization Type
Associate Principal Scientist, Statistical Programming - SDTM-STA000846


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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

The Associate Principal Scientist, Statistical Programming - SDTM, provides oversight and creation of SDTM deliverables for analysis and reporting and World-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes creation and validation of SDTM study data standard deliverables (SDTM dataset, Define.XML, SDRG, aCRF), collaborating and consulting with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards.

The incumbent will be responsible for continuous improvement of our electronic submission process for study data standards deliverables and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness. The position is a key collaborator with statistical programming, statistics, global data management and other project stakeholders and ensures project plans are executed efficiently with timely and high quality deliverables. For assigned studies the position serves as the statistical programming point of contact and knowledge holder.

Primary Activities:

- Supporting project teams in creating SDTM deliverables for A&R and submission,

- Collaborating with project teams to prepare the CRT submission deliverables including use of Pinnacle 21 Enterprise,

- Up-versioning activities to specific versions of SDTM

- Participation in industry teams and conferences on best practices

- Membership on departmental strategic initiative project teams



- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with a minimum of 9 years SAS programming experience in a clinical trial environment

- MS (preferred) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with a minimum of 7 years SAS programming experience in a clinical trial environment

Required Experience:

- Expertise in SAS and clinical trial programming

- Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)

- US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of CRT SDTM study data standard deliverables

- Strong knowledge and experience with study data standards CDISC CDISC (SDTM), Define.XML, SDRG, aCRF; knowledge of ADaM and ADRG considered a plus

- Excellent communication and interpersonal skills and ability to negotiate and collaborate effectively

- Excellent written, oral, and presentation skills

- Excels in technical writing, able to convert complex ideas and information into simple readable form

- 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

- Demonstrated success in the assurance of deliverable quality and process compliance.

- Familiarity with statistics and clinical data management concepts

Preferred 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

- Deals well with change and seamlessly assimilates to new projects and stakeholders

- Ability to anticipate stakeholder requirements

- Strategic thinking – ability to turn strategy into tactical activities

- 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 industry forums and professional societies

- Experience in process improvement

- Familiarity with Meta Data Repositories

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need an accommodation for the application process please email us at

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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, 10 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck

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