Director, Statistical Programming

3 weeks ago

Rahway, New Jersey, United States Merck Full time

Job Description

Responsibilities:

  • Responsible for both people and project management and is accountable to set strategy for the delivery of high quality and compliant statistical analysis and reporting.
  • Direct the activities of programmers whose predominant accountability is the development, validation and execution of programs creating analysis datasets, tables, listings, figures and submission deliverables for drug and vaccine programs.
  • Interact with cross functional scientists including, Statistics, Clinical, Regulatory, QP2, CSRM, Data Management and Statistical Programming to plan for the statistical analysis and reporting of clinical drug and vaccine projects.
  • Set direction for the analysis and reporting deliverables.
  • Negotiate and prioritize resource assignments with staff and stakeholders at a regional or global level ensuring that project plans are executed efficiently with timely and high-quality deliverables.
  • Manage the analysis and reporting deliverables of Functional Sourcing Partners.
  • Ensure appropriate and consistent application of SOPs, standards and quality and compliance measures.
  • Engage with cross functional stakeholders to identify areas for improvement and solve business challenges.
  • Establish strong partnerships with statistical stakeholders in BARDS LDS, EDS, CSS.
  • Provide technical and/or scientific guidance to employees and colleagues.
  • Manage staff resources including resource allocation and forecasting; and identify solutions to address resource and operational challenges.
  • Contribute to building and fostering group capability for the delivery of expertise, and behaviors required to deliver success on projects.
  • Hire appropriate, qualified staff.
  • Complete performance management and employee development including coaching and mentoring.
  • Manage training plans.
  • Lead and actively contribute to departmental strategic objectives.
  • Represent Statistical Programming at a leadership level; be a visible contributor and decision maker.
  • Interface externally in industry activities.
  • Will supervise at least 8 employees.

Requirements:

  • Must have a Bachelor's degree (or its U.S. equivalent) in Computer Science, Statistics, Applied Mathematics, Biological Sciences, Engineering or related field plus at least twelve (12) years SAS programming experience in a clinical trial environment or a Master's degree (or its U.S. equivalent) in Computer Science, Statistics, Applied Mathematics, Biological Sciences, Engineering or related field plus at least ten (10) years SAS programming experience in a clinical trial environment.
  • Experience must also include at least seven (7) years of experience in project management in the development and execution of statistical analysis and reporting deliverables.
  • Experience in people management with demonstrated ability to lead and develop people; expertise in managing and forecasting programming resources at the project and therapeutic area level; broad knowledge and demonstrated experience in developing analysis and reporting statistical programming deliverables using global and TA standards and according to quality, compliance and timeliness requirements; expertise in SAS and clinical trial programming, systems and databases including advanced knowledge of CDISC data standards; experience leading the activities of a programming team that includes functional sourcing partners, domestic contractors, and global resources; and ability and interest to work across cultures and geographies also required.
  • Must also have US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of submission deliverables; and knowledge of regulatory agency requirements pertaining to statistical computing and programming issues.
  • Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; ability to deal well with change and to seamlessly assimilate to new projects and stakeholders; and ability to engage key stakeholders also required.
  • Must possess demonstrated success in the assurance of deliverable quality and process compliance; and strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC).
  • 40 hours per week: M-F- 9am-5pm.
  • Must have proof of legal authority to work in the US.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

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.

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/31/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:05/31/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R280649

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