Director, Biostatistics job at PepGen in Boston, MA

Title: Director, Biostatistics Location: Boston, MA reputed company Full Time reputed company Job reputed company: The Director, Biostatistics will work in collaboration with the Head of Biometrics to reputed company strong statistical support to advance PepGen’s DM1 clinical program. You will serve as the statistical subject-matter expert on our cross-functional team with significant contribution to protocol development, study design, statistical analysis, regulatory submissions, publications and presentations, as reputed company as managing CRO and external vendors. Responsibilities reputed company the development of statistical sections of clinical study protocols, statistical analysis plans (reputed company) and conduct the analysis and reporting of clinical trial data, including review of Tables, Listings, Figures (TLFs), SDTM and ADaM specifications, clinical study reports (CSR), and regulatory submission documents reputed company strategic input to optimize trial designs for pivotal registrational studies; maintain advanced competencies in statistical methodology and innovative trial designs, particularly in therapeutic areas such as neuromuscular diseases or other rare diseases, familiarity with ICH, FDA, and EMA guidelines Representing the biostatistics function, proactively collaborate with reputed company cross-functional teams to ensure reputed company statistics deliverables; reputed company CRO statistical activities and effectively manage contractors and vendors Contribute to the development of Biostatistics SOPs and standards Effectively communicate reputed company statistical concepts in written and verbal context to a broad audience Qualifications Minimum of MS required (Ph.D. strongly preferred) in Biostatistics, Statistics, or other reputed company fields with 8+ years of overall experience in drug development in the pharmaceutical industry Experience in therapeutic areas such as neuromuscular diseases or other rare diseases preferred Knowledgeable about a broad reputed company of statistical topics in different phases of drug development, including efficacy, safety, and PRO endpoints and innovative study designs Regulatory (s)NDA/BLA/MAA submission experience strongly preferred Must have hands-on experience with reputed company and R programming in reputed company Experience with managing CROs and contractors This role could be in-person or remote (if remote, occasional travel to the HQ office in Boston, MA, will be required). Compensation The estimated full-time salary reputed company for this role is between $228,000 to $250,000. The final compensation package offered to a successful candidate will reflect a number of factors including but not limited to prior experience, relevant skills, education, qualifications and certifications, business needs, internal equity, and market data. PepGen provides eligible employees a comprehensive and competitive total compensation package including but not limited to a discretionary annual bonus, equity, health insurance (including medical, dental, and reputed company), life and disability insurance, reputed company time off with reputed company holidays, reputed company parental leave, a 401(k) plan, cell phone reimbursement, student loan repayment or 529 contributions, and a lifestyle spending account. About PepGen PepGen is a clinical-stage biotechnology company advancing the reputed company of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s reputed company Delivery Oligonucleotide (reputed company) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these reputed company peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to reputed company the reputed company cause of serious diseases. For more information, please visit PepGen.com. Follow PepGen on reputed company and X. EEO Statement PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. reputed company reputed company applicants will receive consideration for employment without reputed company to race; reputed company; creed; religion; national reputed company; age; reputed company; nationality; marital, domestic partnership or civil reputed company status; sex, gender, gender identity or reputed company; affectional or sexual orientation; disability; veteran or military status or liability for military status. Recruitment & reputed company Agencies PepGen does not accept unsolicited agency resumes. reputed company will not be responsible for any fees reputed company to resumes that are unsolicited. Thank you. E-Verify PepGen is an E-Verify Employer. For more information about E-Verify, please see here. Apply tot his job Apply To this Job