Executive Director, Biostatistics
4 weeks ago
The incumbent will translate R&D objectives into relevant work products, establish statistical strategies and ensure quality execution. The position will be a combination of conducting complex statistical analyses, developing SAPs and contributing to regulatory documents. In addition to hands–on work, the incumbent will also coordinate with other biostatisticians/programmers on execution of other statistical deliverables.
This position reports into Chief Data and Analytics Officer of Madrigal Pharmaceuticals.
Position Responsibilities: This role will oversee and coordinate with other biostatisticians/programmers either within Madrigal or at a CRO in support of executing R&D activities.Contribute to clinical/regulatory strategies, submission documents and lifecycle management activities to ensure the company's clinical programs and data assets are optimally designed and executed.Perform complex statistical analyses, contribute to protocol development, and prepare Statistical Analysis PlansRepresents the company in external scientific and industry forums. Engages in interactions with both external clinical and statistical thought leaders.Establishes effective collaborations with cross–functional project team members, such as clinical research, clinical operations, data management and pharmacovigilance.Establishes strong working relationships with external CRO and vendor partners.Mentors and contributes to more junior members in R&D. Qualifications and Skills Required: Ph.D. in Statistics or Biostatistics with 10+ years of experience in Pharma or Biotech companiesProven experience in supporting NDA regulatory submissions, and meeting with health authorities (e.g, FDA, EMA, PMDA)Demonstrated expertise in advanced statistical methods and clinical trial design and able to conduct them as needed.Effectively communicates complex statistical analyses and issues to non–statisticians.In–depth knowledge of regulatory guidelines in pharmaceutical development.Excellent organizational and communication skills. Compensation:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance. Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established. Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals' Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal's name and logo in an attempt to solicit up–front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.
Please also note that any correspondence with regard to employment would come from an authorized email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.
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